Artificial heart valve

Abstract

The prosthetic heart valve includes an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, multiple openings, and a longitudinal axis; multiple commissure support members on the exterior of the frame; and multiple quadrilateral leaflets, each of which has a main body with an inflow edge and an outflow edge and a pair of opposing leaflet tabs extending from either side of the main body, each leaflet tab paired with an adjacent leaflet tab of an adjacent leaflet, each pair of leaflet tabs extending through a respective opening in the frame and coupled to one of the commissure support members to form a commissure tab assembly, each commissure tab assembly located on the exterior of the frame and the main body of each leaflet located on the interior of the frame.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 006,190, filed Apr. 7, 2020, which is incorporated herein by reference.

[0002] The present disclosure relates to an artificial heart valve and also to a method and assembly for forming a leaflet assembly and attaching the leaflet assembly to a frame of such an artificial heart valve.

Background Art

[0003] The human heart can be affected by various valvular diseases. These valvular diseases can cause significant heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are several known repair devices (e.g., stents) and artificial valves, as well as several known methods for implanting these devices and valves into humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver an artificial medical device to an internal location in the body where surgical access is not easily available or access without surgery is desirable. In one specific example, an artificial heart valve is mounted on the distal end of a delivery instrument in a crimped state and can be advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the artificial heart valve reaches the implantation site within the heart. The artificial heart valve is then expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted, activating a mechanical actuator that applies an expanding force to the artificial heart valve, or deploying the artificial heart valve from the sheath of the delivery instrument such that the artificial heart valve self - expands to its functional size.

[0004] Most expandable transcatheter heart valves are used for intermediate to high expansion diameters, e.g., diameters in the range of 23 - 29 mm. Smaller prosthetic valves are available, such as those with diameters of about 20 mm or less, but valves with smaller diameters are rarely used due to various difficulties. For example, smaller diameter prosthetic valves generally cause higher pressure gradients along the prosthetic valve, which can lead to various clinical risks such as cavitation. Also, smaller prosthetic valves typically have shorter paravalvular sealing elements, which makes it even more difficult for clinicians to align the prosthetic valve at the native annulus. Smaller prosthetic valves may also have a relatively short frame, resulting in prolapse of the native leaflets, which protrude into the outflow end of the prosthetic valve, thereby obstructing blood flow and / or inhibiting complete opening of the prosthetic leaflets. Further, smaller prosthetic valves have relatively small frame openings, which can inhibit catheter access through the frame for subsequent procedures such as coronary access. Finally, valve-in-valve procedures involving implantation of a second prosthetic valve into a previously implanted prosthetic valve are even more difficult with relatively small prosthetic valves because it is more difficult to properly align and orient the second prosthetic valve inside the previously implanted prosthetic valve while maintaining access to the coronary ostia.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

[0006] Accordingly, there is a need for an improved artificial heart valve leaflet assembly and a method of assembling the leaflet assembly to an artificial heart valve frame. [Means for Solving the Problems]

[0007] Described herein are methods of assembling an artificial heart valve including a leaflet assembly, methods of assembling a leaflet subassembly of the leaflet assembly, and embodiments of an artificial heart valve including a leaflet assembly.

[0008] In one representative embodiment, an artificial heart valve is provided. The artificial heart valve includes an expandable annular frame, a plurality of cross-linked support members outside the frame, and a plurality of quadrilateral leaflets. The expandable annular frame has an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis. Each of the plurality of quadrilateral leaflets has a main body having an inflow edge and an outflow edge, and a pair of opposing leaflet tabs extending from both sides of the main body. Each leaflet tab is paired with an adjacent leaflet tab of an adjacent leaflet. Each pair of leaflet tabs extends through a respective opening of the frame and is connected to one of the cross-linked supports to form a cross-linked tab assembly. Each cross-linked tab assembly is located on the exterior of the frame, and the main body of each leaflet is located on the interior of the frame. The inflow edge of the leaflet and the inflow end of the frame are aligned, and the outflow edge of the leaflet is axially displaced (offset) from the outflow end of the frame along the longitudinal axis.

[0009] In another exemplary embodiment, the artificial heart valve includes an annular frame having an inflow end, an outflow end, a plurality of openings, and a longitudinal axis; a plurality of cross-linked support members each having an outer surface and an inner surface; and a plurality of valve leaflets each having a main body with an inflow edge and an outflow edge, and a pair of opposing valve leaflet tabs extending from both sides of the main body. Each valve leaflet tab is paired with an adjacent valve leaflet tab of an adjacent valve leaflet, and each pair of valve leaflet tabs extends through a respective opening of the frame and is connected to one of the cross-linked supports outside the frame to form a cross-linked tab assembly. Each valve leaflet tab forms a first fold that extends radially outward from the main body of the respective valve leaflet through the respective opening of the frame, a second fold that extends circumferentially between the inner surface of the respective support member and the outer surface of the frame, and a third fold that extends circumferentially along the outer surface of the support member.

[0010] In another exemplary embodiment, the artificial heart valve includes an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of cross-linked support members outside the frame; and a plurality of valve leaflets each having a main body with an inflow edge and an outflow edge, and a pair of opposing valve leaflet tabs extending from both sides of the main body. Each valve leaflet tab is paired with an adjacent valve leaflet tab of an adjacent valve leaflet, and each pair of valve leaflet tabs extends through a respective opening of the frame and is connected to one of the cross-linked supports to form a cross-linked tab assembly, each cross-linked tab assembly being located on the exterior of the frame and the main body of each valve leaflet being located on the interior of the frame. In each cross-linked tab assembly, the cross-linked support member has a height greater than the height of the respective frame opening through which the pair of valve leaflet tabs extends.

[0011] In another exemplary embodiment, a leaflet assembly for an artificial heart valve includes a plurality of leaflets and a plurality of commissural support members. Each leaflet includes a main body having an inflow edge and an outflow edge, and opposing commissural tabs extending from opposite sides of the main body. Each commissural support member has a pair of opposing faces. Each commissural tab is paired with an adjacent commissural tab of an adjacent leaflet, and for each pair of commissural tabs, the commissural tabs are partially wrapped around and connected to one of the opposing faces of the support member to form a commissural assembly.

[0012] In another exemplary embodiment, a method of assembling an artificial heart valve is provided. The method includes forming a leaflet assembly from a plurality of leaflets, each leaflet including opposing commissural tabs, the leaflet assembly being formed by pairing the commissural tabs of each leaflet with adjacent commissural tabs of adjacent leaflets and connecting each pair of commissural tabs to a commissural support member to form respective commissural assemblies of the leaflet assembly. The method further includes positioning the leaflet assembly inside an expandable annular frame, the frame defining a plurality of openings; and inserting each of the commissural assemblies through a respective opening of the frame and positioning the commissural assemblies outside the frame.

[0013] The foregoing objects, features, and advantages of the present invention, as well as other objects, features, and advantages, will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

[0014]

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DETAILED DESCRIPTION OF THE INVENTION

[0015] This specification describes embodiments of artificial implants, such as artificial valves that can be implanted in any of the native valves of the heart (e.g., aortic valve, mitral valve, tricuspid valve, and pulmonary valve). The present disclosure also provides a frame for use with such artificial implants. The frame may include struts having different shapes and / or sizes to avoid coronary artery occlusion and prolapse of the native valve leaflets. The artificial heart valve may also include a plurality of valve leaflets attached to the frame.

[0016] The present disclosure may also include a leaflet assembly for an artificial heart valve, a leaflet commissure tab assembly for the leaflet assembly, and a method of assembling the leaflet commissure tab assembly. The leaflet commissure tab assembly may include a plurality of leaflet commissure support members. Each leaflet commissure tab assembly may include a pair of adjacent leaflet tabs connected to each other by a commissure support member. Each leaflet commissure assembly may be formed by folding and securing each tab of the leaflet around a corresponding commissure support member. Adjacent leaflets may then be connected to each other before being attached to the frame of the artificial heart valve. As a result, the leaflet assembly for the artificial heart valve can be assembled more easily away from the frame of the artificial heart valve, and the time and effort for securing the leaflet assembly to the frame of the artificial heart valve can be reduced.

[0017] This specification also discloses various small-diameter artificial valves (e.g., 20 mm) that can address one or more of the drawbacks associated with the previously described known small-diameter artificial valves. Specifically, the disclosed embodiments can be configured to reduce pressure gradients, avoid prolapse of the native valve leaflets, and / or maintain access to and blood flow in the coronary arteries, all aspects generally associated with smaller diameter valves. The disclosed embodiments may include a plurality of commissure tab assemblies of a leaflet assembly connected to the outer surface of the frame. The disclosed commissure tab assemblies can, for example, enable the leaflets to open wider than is generally possible with conventional valves, thereby increasing the overall blood flow through the artificial valve and reducing high pressure gradients.

[0018] The prosthetic valve disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto an implant delivery device in a radially compressed state during delivery or held by the implant delivery device and then expanded to a radially expanded state when the prosthetic valve reaches the implantation site. It is understood that the valves disclosed herein can be used with a variety of implant delivery devices.

[0019] FIG. 1 shows an exemplary artificial heart valve 100 according to one embodiment. The artificial heart valve 100 can be radially compressed and expanded between a radially compressed configuration for delivery into a patient's body and a radially expanded configuration. In certain embodiments, the artificial heart valve 100 can be implanted within the native aortic valve annulus, but can also be implanted in other locations within the heart, including within the native mitral valve, native pulmonary valve, and native tricuspid valve. The artificial heart valve 100 can include an annular stent or frame 102 having a first end 104, a second end 106, an inner surface 108, and an outer surface 110.

[0020] In the depicted embodiment, the first end 104 is the inflow end and the second end 106 is the outflow end. The outflow end 106 can be coupled to a delivery device for delivery, and implantation of the artificial heart valve into the native aortic valve is a retrograde delivery approach via the transfemoral artery. Thus, in the delivery configuration of the artificial heart valve, the outflow end 106 is the most proximal end of the prosthetic valve. In other embodiments, the inflow end 104 can be coupled to the delivery device depending on the particular native valve being replaced and the delivery technique used (e.g., transseptal, transapical, etc.). For example, the inflow end 104 can be coupled to the delivery device when delivering the artificial heart valve to the native mitral valve via a transseptal delivery approach (and thus is the most proximal end of the artificial heart valve in the delivery configuration).

[0021] As shown in FIGS. 1 and 2, the frame 102 may include a plurality of interconnected lattice struts 112 that are arranged in a lattice pattern and form a plurality of tops 114 at the outflow end 106 of the prosthetic valve 100. The struts 112 may also form similar tops 116 at the inflow end 104 of the prosthetic valve 100. In FIGS. 1 and 2, the struts 112 are shown as being positioned obliquely with respect to the longitudinal axis 118 of the prosthetic valve 100, or angled and offset from the longitudinal axis 118, and radially offset from the longitudinal axis 118 when the prosthetic valve 100 is in the expanded configuration. In other embodiments, the struts 112 may be offset by a different amount than depicted in FIG. 1, or some or all of the struts 112 may be positioned parallel to the longitudinal axis 118 of the prosthetic valve 100.

[0022] The frame 102 can be made of any of a variety of suitable plastically expandable materials, such as stainless steel or cobalt-chromium alloy, and / or self-expanding materials, such as nickel-titanium alloy (“NiTi”), such as Nitinol. When constructed of a plastically expandable material, the frame 102 (and thus the prosthetic valve 100) can be crimped in a radially compressed state on a delivery catheter and then expanded inside the patient by an inflatable balloon or any suitable expansion mechanism. When constructed of a self-expanding material, the frame 102 (and thus the prosthetic valve 100) can be crimped in a radially compressed state and constrained in the compressed state by insertion into the sheath of a delivery catheter or an equivalent mechanism. Once inside the body, the prosthetic valve 100 can be advanced from the delivery sheath, whereby the valve can expand to its functional size.

[0023] Still referring to FIGS. 1 and 2, frame 102 may include a plurality of circumferentially extending rows of interconnected struts 112 arranged in a lattice pattern. In the illustrated embodiment, the open lattice structure of frame 102 may define a plurality of rows of open frame apertures 120 between struts 112. As shown in FIGS. 1 and 2, frame apertures 120 can be diamond-shaped. Frame apertures 120 are arranged in a plurality of circumferentially extending rows including a bottommost row at the inflow end of the frame, a topmost row at the outflow end of the frame, and one or more intermediate rows between the bottommost row and the topmost row. In the illustrated embodiment, there are four rows of frame apertures, and all of the apertures within a given row are of the same size and shape.

[0024] In the illustrated embodiment, struts 112 are pivotable or bendable relative to each other to allow for radial expansion and contraction of frame 102. For example, frame 102 can be formed from a single piece of material (e.g., a metal tube) (e.g., via laser cutting, electroforming, or physical vapor deposition). Thus, when the inflow end 104 and outflow end 106 of frame 102 are radially expanded or compressed, such as during the assembly, preparation, or implantation of artificial valve 100, they can move axially parallel to the longitudinal axis 118 of artificial valve 100.

[0025] In other embodiments, frame 102 can be constructed by forming individual components (e.g., frame struts and fasteners) and then mechanically assembling and connecting the individual components to each other. For example, struts 112 can be pivotally connected to each other at one or more pivot joints or pivot points along the length of each strut. Each pivot joint or pivot point (e.g., a hinge) can allow struts 112 to pivot relative to each other when frame 102 is radially expanded or compressed.

[0026] Further details regarding the construction of the frame and prosthetic valve are described in Patent Document 1, which is incorporated herein by reference. Other frames that can be implemented in a prosthetic valve are disclosed in Patent Documents 2, 3, and 4, which are incorporated herein by reference.

[0027] The prosthetic valve 100 may also include a valve structure 122 that is coupled to and supported by the frame 102. The valve structure 122 is configured to regulate the flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 106. The valve structure 122 may include, for example, a leaflet assembly that includes one or more leaflets 124 made of a flexible material. The leaflets 124 may be made in whole or in part from a biological material, a biocompatible synthetic material, or other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 124 can be fixed to each other at their adjacent sides to form commissures 126, which can each be fixed to commissure support members 128, as further discussed below.

[0028] As shown in FIGS. 3-5A, each leaflet 124 of the valve structure 122 can be configured to have a quadrilateral shape (e.g., a rectangle or a square as shown in the figures), and can have an inflow edge 132 and an outflow edge 134 (also referred to as a fusion edge), which contacts the respective outflow edge of the other leaflets during closure of the leaflets 124 (e.g., during diastole).

[0029] Leaflets commonly found in prosthetic valves typically have a curved scalloped shape, e.g., a downwardly pointed edge portion that curves between the tabs of each leaflet. As a result, prosthetic leaflets are often attached to the frame in a scalloped pattern with their lowest points (e.g., the points closest to the inflow end of the valve) offset from the inflow end of the valve.

[0030] As shown in FIGS. 1 and 3 - 4, the inflow edge 132 of the quadrilateral valve tip 124 of the valve structure 122 is aligned (or substantially aligned) with the inflow end 104 of the frame 102 and can be attached to the inflow end 104. Thus, each valve tip 124 may also have an outflow end 134 that is axially displaced from the outflow end 106 of the frame along the longitudinal axis 118 of the valve 100. In this way, the outflow edge 134 of each valve tip can be positioned between the inflow end 104 and the outflow end 106 of the frame 102, opening and making accessible the frame opening 120 or a portion thereof downstream of the outflow edge during the operating cycle of the prosthetic valve 100, thereby reducing the potential occlusion of the coronary artery by the valve tip 124.

[0031] As best shown in FIG. 3, the outflow edge 134 of the valve tip 124 is perpendicular to the longitudinal axis 118 and upstream of a plane P that bisects each of the openings 120 in the uppermost row of openings at the outflow end of the frame. In this way, most of each of the uppermost row of frame openings 120 is not covered by the valve tip 124 in their open positions, thereby providing access to the coronary artery. In some embodiments, at least 60% of the frame openings in the uppermost row are not covered by the valve tip 124 in their open positions; more desirably, at least 80% of the frame openings in the uppermost row are not covered by the valve tip 124 in their open positions; more desirably, at least 80% of the frame openings in the uppermost row are not covered by the valve tip 124 in their open positions; more desirably, at least 90% of the frame openings in the uppermost row are not covered by the valve tip 124 in their open positions; more desirably, 100% of the frame openings in the uppermost row are not covered by the valve tip 124 in their open positions.

[0032] As shown in FIG. 5A, each valve tip 124 of the valve structure 122 can have a main body 143 that defines an inflow edge 132 and an outflow edge 134, and valve tip tabs 144a, 144b (also referred to as cross - connecting tabs) that extend from both sides of the main body 143. Each valve tip 124 can have a valve tip height H1 defined by the length extending from the inflow edge 132 (e.g., at the inflow end 104) to the outflow edge 134, and a width W1 measured from one side of the main body 143 to the other side of the main body. In the illustrated embodiment, each valve tip 124 has a rectangular shape with a width W1 greater than the height H1. Although the prosthetic valve 100 is described herein as having quadrilateral valve tips, other configurations and structures of the valve tips can be used.

[0033] As further shown in FIG. 5A, each valve tip tab 144a, 144b in the illustrated embodiment has a height or length L2 measured from the outflow edge 162 of the valve tip tab to the inflow edge 164 of the valve tip tab 164. The outflow edge 162 may be axially offset from the outflow edge 134 of the main body 143 in the upstream direction, and the inflow edge 164 may be axially offset from the inflow edge 132 of the main body 143 in the downstream direction.

[0034] The frame 102 can also have a diameter D and a height H2 defined by the length of the frame 102 that extends along the longitudinal axis 118 between the outermost point of the top 116 of the inflow end 104 and the top 114 of the outflow end 106.

[0035] The selection of the height of the frame of the artificial valve is a particularly important issue, especially for artificial valves with a smaller diameter (e.g., 20 mm or less). Generally speaking, the frame of the artificial valve preferably extends beyond the line of the sinotubular junction (STJ) and is short enough to avoid tilting of the artificial valve from its intended implantation orientation, but long enough to avoid self-cusp protrusion. In patients who require a relatively small artificial valve (20 mm or less), an artificial valve with a height of about 14 mm or less may increase the risk of cusp protrusion, while the inventors have discovered that an artificial valve with a height exceeding 18 mm may extend beyond the line of the STJ.

[0036] The selection of the height of each individual cusp is also an important issue for artificial valves with a smaller diameter. Generally speaking, the cusp must be high enough to promote complete closure of the cusp during diastole, for example, to prevent unwanted backflow through the artificial valve. On the other hand, the cusp must also be low enough not to obstruct access to the coronary arteries when in the open and closed configurations.

[0037] Thus, in some embodiments, the artificial valve 100 may have a valve diameter D in the range of 18 mm to 22 mm, more specifically 19 mm to 21 mm, with 20 mm being a specific example; the frame height H2 can be in the range of 15 mm to 18 mm, more specifically 16 mm to 17 mm, with 15.5 mm being a specific example; each cusp 124 may have a height H1 in the range of 11 mm to 14 mm, more specifically 12 mm to 13 mm, with 12 mm being a specific example. The inventors have discovered that an artificial valve having these dimensions can reduce the risk of cusp protrusion and avoid the line of the STJ, and can also achieve complete closure of the cusp and avoid obstructing coronary artery access.

[0038] Furthermore, by using the quadrilateral valve tip 124, the prosthetic valve 100 is constructed with a minimum valve tip height H1 (e.g., 11 mm). For example, the quadrilateral shape of the valve tip 124 increases the surface area of the valve tip 124 that contacts the blood flow entering the valve 100 without the need to use a higher (e.g., longer) valve tip commonly used in valves having scalloped valve tips. By constructing the prosthetic valve 100 with the quadrilateral valve tip 124 having a low valve tip height H1, the resistance across the valve 100 can be reduced and the opening of the valve tip will widen during the operating cycle of the valve. Accordingly, the overall pressure gradient across the valve can be reduced. In some embodiments, the pressure gradient across the prosthetic valve 100 can be further reduced by using a smooth valve tip and / or thinning the valve tip, e.g., by sourcing, skiving, and / or laser milling.

[0039] According to the embodiments described herein, the diameter D and height H2 of the frame 102 can have a proportional relationship to each other and each can have a proportional relationship to the valve tip height H1 of the valve tip 124. For example, the prosthetic valve 100 can have a ratio D / H2 in the range of about 1.24 to 1.34, a ratio D / H1 in the range of about 1.61 to 1.71, and a ratio H2 / H1 in the range of about 1.24 to 1.34. In some embodiments, the prosthetic valve 100 can have a ratio D / H2 in the range of about 1.0 to 1.5, a ratio D / H1 in the range of about 1.3 to 1.9, and a ratio H2 / H1 in the range of about 1.0 to 1.5 since the dimensions of the prosthetic valve are adjustable. In other embodiments, the ratio D / H2 is approximately equal (or substantially equal) to the ratio H2 / H1. In further embodiments, the ratio D / H1 is greater than or equal to the ratio D / H2 and / or the ratio H2 / H1.

[0040] Referring to FIG. 3, in some embodiments, one or more of the frame openings 120 above the outflow edge 134 of the valve tip 124 have a maximum width W4 and height H3 (measured from the outflow edge of the valve tip to the inner edge of the top 114) that are greater than the diameter of their native ostia. In certain embodiments, the width W4 and height H3 are at least 2 mm (which may allow a 6Fr coronary catheter to pass through the opening), or in some embodiments at least 4 mm, or in some embodiments at least 6 mm. In some embodiments, one or more of the frame openings 120 above the outflow edge 134 have a width W4 and height H3 that are twice the diameter of the native ostia into which the prosthetic valve is implanted.

[0041] In the illustrated embodiment, the frame 102 has 12 openings 120 in each horizontal row of openings. In other embodiments, each horizontal row of openings 120, or at least the horizontal row at the outflow end of the frame, may have fewer openings 120 to increase the maximum width W4 of each opening. For example, in some embodiments, at least the upper horizontal row at the outflow end of the frame may have 9 openings 120. Further, the number of horizontal rows of openings along the height H2 of the frame 102 can be less than 4, such as 2 or 3 horizontal rows of openings 120, to increase the height H3 of the horizontal row of openings at least at the outflow end of the frame.

[0042] FIG. 4 shows a perspective view of the prosthetic valve 100 in the cranio-caudal direction with one of the valve tips 124 of the valve structure 122 removed for illustrative purposes. As shown in FIG. 4, the valve structure 122 may include a valve tip assembly having a plurality of valve tips 124, a valve tip contact region 126, and a commissural tab assembly 130.

[0043] As shown in FIG. 5A, each valve tip 124 of the artificial valve 100 (e.g., FIG. 1) may have a pair of opposing valve tip tabs 144a, 144b (e.g., opposing side portions) that extend laterally from the main body 143 of the valve tip between the inlet edge 132 and the outlet edge 134 of the main body 143, and the edges 132, 134 define the height H1 of the valve tip 124 and the main body 143. In the illustrated embodiment, the valve tip tabs 144a, 144b may have a length L2 that is less than the height H1 of the valve tip. In this configuration, the valve tip tabs 144a, 144b can extend circumferentially around their respective support members 128 and can extend through the opening 120 without deforming the main body 143 of the valve tip 124 positioned inside the frame 102. Thus, the valve tip tabs 144a, 144b may have a length L2 that is equal to (or substantially equal to) the length L1 of the cross-linking tab assembly 130.

[0044] Referring to FIGS. 4 and 6, each cross-linking tab assembly 130 of the valve structure 122 may include a pair of valve tip tabs 144 connected to their respective support members 128. For example, as shown in FIG. 6, each pair of valve tip tabs 144 from adjacent valve tips 124 (e.g., individual valve tips 124) can contact each other to form their respective contact regions 126 from which the valve tip tabs 144 extend and wrap around the surfaces (e.g., inner and outer surfaces) of their respective cross-linking support members 128.

[0045] As shown in FIG. 6, each valve tip tab 144 may form a first radially extending fold 144a, a second circumferentially extending fold 144b that is radially inside the support member 128, and a third circumferentially extending fold 144c that is radially outside the support member 128. The second fold 144b extends along the inner surface 166 of the support member 128, and the third fold extends along the outer surface 168 of the support member 128. In some embodiments, the valve tip tabs 144 can each extend around and wrap around the cross-linking support member 128 such that one valve tip tab overlaps the other valve tip tab.

[0046] In the illustrated embodiment, each support member 128 is in the form of a rectangular plate having flat and parallel inner surface 166 and outer surface 168. In alternative embodiments, the support member 128 can have various other shapes, such as cylindrical, square, etc.

[0047] The valve tip tab 144 can also be fixed to the cross-linking support member 128 by one or more sutures 148 that extend through and / or around each of the adjacent valve tip tabs 144 and cross-linking support members 128 to form the cross-linked tab assembly 130. For example, as best shown in FIG. 4, each valve tip tab 144 can be fixed to the cross-linking support member 128 with one or more sutures 148 that form in-and-out stitches extending through the second fold 144b, the hole 150 in the cross-linking support member 128, and the third fold 144c.

[0048] As shown in FIGS. 4 and 7A-7C, the cross-linking support member 128 is a rigid plate-like structure (or a partially rigid structure) made of various materials, including polymers, stainless steel, cobalt-chromium alloys, or nitinol, and / or combinations thereof, and can have a plurality of holes 150 sized and arranged to receive one or more sutures 148. In the illustrated embodiment of FIGS. 4 and 7A, the holes 150 in the support member 128 are arranged in two vertical (or alternatively, horizontal) rows along the length L3 and sides 146 of the cross-linking support member 128. The arrangement of the holes 150 shown in FIG. 7A can, for example, allow one or more sutures 148 to extend in and out of the holes 150 and also through the second fold 144b and third fold 144c of the valve tip tab 144 in the illustrated embodiment depicted in FIG. 4. In some embodiments, the length L3 of the support member 128 can be greater than, less than, or equal to the height H1 of the valve tip 124 and / or the length L2 of the valve tip tab 144.

[0049] In other embodiments, such as those illustrated in FIGS. 7B-7C, in the exemplary embodiments, the holes 150 of the support member can be arranged in various configurations. For example, as shown in FIG. 7B, the support member 128' can have an alternating (or staggered) configuration, such that one of two rows that are repeated along the length of the support member can have one or more additional holes 150 compared to the other. Alternatively, as shown in FIG. 7C, the support member 128'' can have a single vertical row of holes 150 arranged in a straight line along the length (e.g., L3) of the cross-linked support member 128''. In some embodiments, the support member can have holes 150 of any number, arrangement, diameter, and / or shape for receiving one or more sutures 148.

[0050] In a typical prior art valve construction, a valve tip assembly including a plurality of valve tips connected at adjacent tabs is disposed within a frame, and the cross-linked assembly is formed by sewing the valve tip tabs to the support members of the frame and / or to other soft components, such as fabric reinforcement members. As can be appreciated, the process of forming the cross-linked assemblies and securing them to the frame is time-consuming and laborious. According to the cross-linked tab assembly 130 described herein, the valve structure 122 of the prosthetic valve 100 can be pre-assembled prior to insertion and attachment to the frame 102. For example, FIGS. 8 and 9 depict a pre-assembled valve structure 122 in which the valve tip tabs 144 of each valve tip 124 are wrapped and secured to their respective cross-linked support members 128 (e.g., by sutures 148). Thus, the entire valve structure, including the cross-linked tab assembly 130, can be pre-assembled before placing the valve tips inside the frame, which can significantly reduce the overall assembly time of the prosthetic valve.

[0051] The pre-assembled valve structure 122 of FIGS. 8 and 9 can be positioned, for example, within (or partially within) the interior of the frame 102 (e.g., the exposed frame of FIG. 2), for example, proximate to the inner surface 108, such that each of the cross-link tab assemblies 130 can be inserted through and into each open frame opening 120 to position the cross-link tab assembly 130 on the exterior (e.g., outer surface 110) of the frame 102. The cross-link assembly 130 can be deformed at the fold 144a to facilitate insertion of the cross-link assembly through each opening 120.

[0052] For example, once the valve structure 122 is positioned within the frame 102, the cross-link tab assembly 130 can be twisted (e.g., bent, rotated, pivoted, etc.) at the fold 144a relative to the main body 143 of the valve tip and the frame 102 (e.g., by 90°). Thereby, one end of each cross-link tab assembly 130 is inserted through each open frame opening 120 until the entire cross-link tab assembly 130 is advanced through the frame opening 120. Once the cross-link tab assembly 130 reaches the exterior of the frame 102 respectively, the cross-link tab assembly 130 can be twisted or moved back to its non-deformed shape, such that it extends parallel to the longitudinal axis 118 along the outer surface of the frame 102. Thus, each cross-link tab assembly 130 can be disposed on the outer surface 110 of the frame 102, the fold 144a extends through the opening 120, and the main body of the valve tip is disposed inside the frame 102.

[0053] Each of the support members 128 can have a dimension larger than the dimension of the frame opening 120 into which the support member is inserted to prevent the cross-linking assembly 130 from being pulled back inwardly into the interior of the frame under normal operating pressure. For example, in the illustrated embodiment, the cross-linking support member 128 has a length L3 (FIG. 7A) greater than the height L4 (FIG. 3) of each open frame opening 120 through which the cross-linking tab assembly extends to prevent the cross-linking tab assembly 130 from being pulled back through the open frame opening 120 under normal operating pressure once it has come onto the exterior of the frame 102. Instead of, or in addition to, having a length L3 greater than the height L4 of the opening 120, each support member 128 can have a width W2 (FIG. 7A) greater than the width W3 (FIG. 3) of each opening to resist withdrawal of the cross-linking assembly 130.

[0054] Once disposed on the outer surface 110, the cross-linking tab assembly 130 can be connected (e.g., sewn) to the frame 102 by one or more sutures 152 that can extend around (or through) the struts 112 of the frame 102, for example, through one or more selected holes 150 of the cross-linking support member 128, through the valve tip tab 144 (e.g., through the folds 144a, 144c).

[0055] The valve structure 122 can also be constructed using any of a variety of valve tip configurations, such as the valve tips shown in the embodiments of FIGS. 5B-5D. As shown in FIG. 5B, the valve structure 224 can be constructed from a single integral piece of valve tip material (e.g., a single pericardial piece) as opposed to individual pieces (e.g., valve tips 124). For example, in the illustrated embodiment of FIG. 5B, the valve structure 224 can define a plurality of valve tips 224a, 224b, 224c, each having a respective main body 243a, 243b, 243c. Each main body has an inflow edge 232 and an outflow edge 234. The main bodies can be interconnected to each other by integrated intermediate valve tip tabs 244b and 244c. The main body 243a can have an integrated outermost tab 244a on one side of the valve structure, and the main body 243c can have an integrated outermost tab 244d on the opposite side of the valve structure.

[0056] The valve structure 224 can be assembled with a plurality of support members 128 similar to those shown in FIG. 8 by wrapping each of the intermediate tabs 244b, 244c around the respective support members 128 and sewing the tabs to the support members, in order to form the respective cross-linking assemblies 130, as described above for the valve structure 122. The two outermost tabs 244a, 244d can be wrapped around and sewn to the same support member 128 to form another cross-linking assembly 130. The pre-assembled valve structure 224 can then be placed within and secured to the frame 102, as described above for the valve structure 122.

[0057] The valve tips 224a, 224b, 224c can have the same (or substantially the same) dimensions, as described above for the valve tip 124, such as the height H1 of the valve tip and / or the length L2 of the valve tip tab.

[0058] As shown in FIGS. 5C - 5D, the valve structure can be constructed with individual or integral valve tips having different valve tip tab dimensions. For example, FIG. 5C shows an individual valve tip 324 having opposing valve tip tabs 344a, 344b that extend a height H1 (e.g., where L2 is equal to H1) as defined by an inlet edge 332 and an outlet edge 334. Thus, the valve tip tabs 344a, 344b can be configured to provide additional strength, support, and / or for a larger opening 120 within the frame 102.

[0059] FIG. 5D shows a valve structure 424 that can be constructed from a single, integral piece of valve tip material (e.g., a single pericardial piece) as opposed to individual pieces (e.g., valve tip 324). The valve structure 424 can define a plurality of valve tips 424a, 424b, 424c, each having a main body 443a, 443b, 443c, respectively. Each main body has an inflow edge 432 and an outflow edge 434. The main bodies can be interconnected with each other by integrated intermediate valve tip tabs 444b and 444c. The main body 443a can have an integrated outermost tab 444a on one side of the valve structure, and the main body 443c can have an integrated outermost tab 444d on the opposite side of the valve structure. The valve structure 424 can be assembled with the support member 128 in the same manner as described above for the valve structure 224. In this embodiment, the overall height H1 of the valve tip can be equal to the length L2 of the valve tip tab.

[0060] As shown in FIG. 1, the inflow edge 132 of each valve tip 124 can be connected to the frame 102 by one or more sutures 160, etc., that extend around (or through) the struts 112 that form a ring at the inflow end 132 of the frame 102 through the valve tip. In some embodiments, the inflow end of the valve tip can be reinforced at the connection to the frame by one or more reinforcing strips (e.g., fabric strips) that extend circumferentially along the outer surface and / or inner surface of each valve tip. Further details regarding the attachment of the inflow edge of the valve tip with and without reinforcing strips are disclosed in Patent Document 5, as well as Patent Documents 1, 2, and 3, which are incorporated herein by reference.

[0061] As best shown in FIG. 10, by disposing the cross-link tab assembly 130 on the outer surface 110 of the frame 102, the contact region 126 between adjacent valve tips 124 is positioned in contact with, or very close to, the inner surface 108 of the frame 102. For each cross-link assembly, the contact region 126 defines a bending axis about which the major body of the valve tip moves during the operating cycle of the valve. Disposing the contact region 126 of each cross-link tab assembly 130 on the inner surface 108 (or in proximity thereto) enables the major body 143 and / or the outflow edge 134 of the valve tip 124 to contact the inner surface 108 of the frame 102 when the valve tip 124 is in the open configuration, thereby maximizing the opening of the valve tip 124. Thus, when the valve structure 122 is in the open state (e.g., during systole), the valve tip 124 opens wider than is generally tolerated by known valves.

[0062] Typically, an artificial valve may include one or more skirts or seal members, such as an inner skirt mounted on the inner surface of the frame. These inner skirts often function as a means of protecting the valve tip from damage (e.g., wear) caused by contact with the frame when the artificial valve is radially compressed and during the operating cycle of the artificial valve. However, wear that generally affects artificial valve tips may be negligible for valves of smaller diameter (e.g., 20 mm or less). Referring to FIGS. 1 and 4, when the valve tip 124 is opened by receiving blood flow, the valve tip 124 can be circumferentially disposed along the inner surface 108 of the frame 102 without an inner skirt between the valve tip 124 and the frame 102 due to the small diameter 138 (e.g., 20 mm or less) of the valve 100. Thus, in relation to the placement of the cross-link tab assembly 130, by omitting the inner skirt that lines the space between the valve tip 124 and the inner surface 108 of the frame 102, the valve tip 124 contacts or is in close proximity to the frame 102, whereby the valve tip can open wider than is normally tolerated.

[0063] In some embodiments, it may be further desirable to omit the inner skirt from the artificial valve 100 in order to prevent or minimize in-growth within the tissue inside the frame 102. Also, as depicted in FIGS. 1 and 3, it may be desirable to omit any fabric components on or adjacent to the commissure assembly 130 in order to prevent or minimize in-growth of tissue that begins at the commissure and may spread inwards through the openings 120 of the frame. For example, in-growth of tissue within the interior of the frame 102 and onto the inner skirt may prevent the valve leaflets 124 from fully opening during systole and may increase the pressure gradient across the valve. In some embodiments, the artificial valve 100 does not include fabric components within the interior of the frame 102, on the commissure tab assembly 130, and / or at least within the inner area of the frame that may contact the movable portions of the valve leaflets 124, thereby avoiding in-growth of tissue in those areas of the artificial valve.

[0064] As shown in FIGS. 13 and 14, the artificial valve 100 may also include an outer skirt 154 mounted on the outer surface 110 of the frame 102. In embodiments where the inner skirt or fabric is omitted from and / or on the frame 102 and the commissure tab assembly 130, the outer skirt 154 may function as a sealing member for the artificial valve 100 by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the artificial valve. The outer skirt 154 may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue). The outer skirt 154 may be attached to the frame 102 using sutures, adhesives, welding, and / or other means of attaching the outer skirt 154 to the frame 102.

[0065] FIG. 15 shows a delivery device 500 according to an embodiment that may be used to implant an expandable artificial heart valve (e.g., the artificial heart valve 100 of FIG. 1 or any of the other artificial heart valves described herein). In some embodiments, the delivery device 500 is specifically adapted to be used to introduce the artificial valve into the heart.

[0066] In the illustrated embodiment of FIG. 15, the delivery device 500 is a balloon catheter that includes a handle 502 and a steerable outer shaft 504 that extends distally from the handle 502. The delivery device 500 may further include an intermediate shaft 506 (which may also be referred to as a balloon shaft) that extends proximally from the handle 502 and distally from the handle 502, and the portion that extends distally from the handle 502 also extends coaxially through the outer shaft 504. Further, the delivery device 500 may further include an inner shaft 508 that extends distally from the handle 502 coaxially through the intermediate shaft 506 and the outer shaft 504 and extends proximally from the handle 502 coaxially through the intermediate shaft 506.

[0067] The outer shaft 504 and the intermediate shaft 506 may be configured to translate longitudinally (e.g., move) relative to each other along the central longitudinal axis 520 of the delivery device 500 to facilitate the delivery and positioning of the prosthetic valve at the implantation site within the patient's body.

[0068] The intermediate shaft 506 may include a proximal end portion 510 that extends proximally from the proximal end of the handle 502 to the adapter 512. A rotatable knob 514 may be mounted on the proximal end portion 510 and may be configured to rotate the intermediate shaft 506 relative to the outer shaft 504 about the central longitudinal axis 520.

[0069] The adapter 512 may include a first port 538 configured to receive a guidewire therein and a second port 540 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 540 may be fluidly coupled to the inner lumen of the intermediate shaft 506.

[0070] The intermediate shaft 506 may further include a distal end portion that extends distally beyond the distal end of the outer shaft 504 when the distal end of the outer shaft 504 is positioned away from the inflatable balloon 518 of the delivery device 500. The distal end portion of the inner shaft 508 may extend distally beyond the distal end portion of the intermediate shaft 506.

[0071] The balloon 518 may be connected to the distal end portion of the intermediate shaft 506.

[0072] In some embodiments, the distal end of the balloon 518 may be connected to the distal end of the delivery device 500, such as to a nose cone 522 (as shown in FIG. 15), or to an alternative component (such as a distal shoulder) at the distal end of the delivery device 500. The intermediate portion of the balloon 518 can cover the valve mounting portion 524 of the distal end portion of the delivery device 500, and the distal end portion of the balloon 518 can cover the distal shoulder 526 of the delivery device 500. The valve mounting portion 524 and the intermediate portion of the balloon 518 can be configured to receive an artificial heart valve in a radially compressed state. For example, as schematically shown in FIG. 15, an artificial heart valve 550 (which can be one of the artificial valves described herein) can be mounted around the balloon 518 at the valve mounting portion 524 of the delivery device 500.

[0073] The balloon shoulder assembly, including the distal shoulder 526, is configured to maintain the artificial heart valve 550 (or other medical device) in a fixed position on the balloon 518 during delivery through the patient's vasculature.

[0074] The outer shaft 504 may include a distal tip portion 528 mounted on its distal end. The outer shaft 504 and the intermediate shaft 506 may be axially translated relative to each other such that when the prosthetic valve 550 is mounted on the valve mounting portion 524 in a radially compressed state (as shown in FIG. 15) and during delivery of the prosthetic valve to the target implantation site, the distal tip portion 528 is positioned adjacent to the proximal end of the valve mounting portion 524. Thus, the distal tip portion 528 may be configured to resist movement of the prosthetic valve 550 relative to the balloon 518 in the proximal, axial direction when the distal tip portion 528 is disposed adjacent to the proximal side of the valve mounting portion 524.

[0075] An annular space may be defined between the outer surface of the inner shaft 508 and the inner surface of the intermediate shaft 506 and may be configured to receive fluid from a fluid source via the second port 540 of the adapter 512. The annular space may be fluidly coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft 508 and the inner surface of the balloon 518. Thus, fluid from the fluid source can flow from the annular space into the fluid passage to inflate the balloon 518 and radially expand and deploy the prosthetic valve 550.

[0076] The inner lumen of the inner shaft may be configured to receive a guidewire therein to direct the distal end portion of the delivery instrument 500 to the target implantation site.

[0077] The handle 502 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery instrument 500. In the illustrated embodiment, for example, the handle 502 includes an adjustment member such as the illustrated rotatable knob 560, which is operably coupled to the proximal end portion of the pull wire. The pull wire may extend distally from the handle 502 through the outer shaft 504 and have a distal end portion fixed to or near the distal end of the outer shaft 504. Rotating the knob 560 increases or decreases the tension in the pull wire, thereby allowing adjustment of the curvature of the distal end portion of the delivery instrument 500. Further details regarding the steering or bending mechanism for the delivery instrument can be found in Patent Document 6, which is incorporated herein by reference.

[0078] The handle 502 may further include an adjustment mechanism 561 that includes an adjustment member such as the illustrated rotatable knob 562, and a related locking mechanism that includes another adjustment member configured as a rotatable knob 578. The adjustment mechanism 561 is configured to adjust the axial position of the intermediate shaft 506 relative to the outer shaft 504 (e.g., for delicate positioning at the implantation site). Further details regarding the delivery instrument 500 can be found in Patent Documents 7 and 8, which are incorporated herein by reference.

[0079] General Considerations It should be understood that the disclosed embodiments may be adapted to deliver and implant an artificial device to any of the native valve annuli of the heart (e.g., the aortic valve annulus, the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus) and may be used with any of a variety of delivery devices for delivering an artificial valve using any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0080] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatus, and systems should in no way be construed as limiting. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the presence of any one or more particular advantages or the solving of any particular problems. The technology from any example can be combined with the technology described in any one or more of the other examples. Considering the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be understood as limiting the scope of the disclosed technology.

[0081] Some of the operations of the disclosed embodiments are described in a particular order for presentation purposes, but this description method should be understood to include permutations unless a particular ordering is required by the specific language used in this specification. For example, operations described sequentially may, in some cases, be permuted or performed simultaneously. Further, for simplicity, the accompanying drawings do not show the various ways in which the disclosed method can be used with other methods. Further, the description may use terms such as "provide" or "achieve" to describe the disclosed method. These terms are high-level abstract concepts of the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular embodiment and are readily identifiable by one of ordinary skill in the art.

[0082] Regarding an artificial heart valve and a transcatheter delivery system, as used herein, "proximal" refers to the position, orientation, or portion of a component that is close to the user and the handle of the delivery system outside the patient, and "distal" refers to the position, orientation, or portion of a component that is further away from the user and the handle and close to the implantation site. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless explicitly defined otherwise.

[0083] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Further, the term "includes" means "comprises". Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and do not exclude the presence of intermediate elements between the items being coupled or associated, unless a specific contrary statement is made.

[0084] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate the discussion of the principles in the drawings and in this specification, but are not intended to be limiting. For example, terms such as "inside", "outside", "top", "down", "interior", "exterior", etc. may be used. Such terms are used to provide some clarity in the description when dealing with relative relationships, particularly with respect to the specifically illustrated embodiments, where applicable. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion may become the "lower" portion simply by turning the object over. Nevertheless, it is still the same portion, and the object remains the same. As used herein, "and / or" means "and" or "or", as well as both "and" and "or".

[0085] Additional Examples of the Disclosed Technology In view of the foregoing embodiments of the disclosed subject matter, this application discloses the additional examples listed below. Note that one or more features of two or more examples, understood separately or in combination, and optionally in combination with one or more features of one or more additional examples, are also additional examples that are included in the disclosure of this application.

Example

[0086] An artificial heart valve, comprising an inflow end portion, an outflow end portion, an interior, an exterior, a plurality of openings, and an expandable annular frame having a longitudinal axis; a plurality of cross-linked support members outside the frame; and a plurality of quadrilateral valve leaflets, each of the plurality of quadrilateral valve leaflets having a main body having an inflow edge and an outflow edge, and a pair of opposing valve leaflet tabs extending from both sides of the main body, each valve leaflet tab being paired with an adjacent valve leaflet tab of an adjacent valve leaflet, each pair of valve leaflet tabs extending through a respective opening of the frame and being connected to one of the cross-linked supports to form a cross-linked tab assembly, each cross-linked tab assembly being located on the exterior of the frame, and the main body of each valve leaflet being located on the interior of the frame; the inflow edge of the valve leaflet and the inflow end portion of the frame being aligned, and the outflow edge of the valve leaflet being axially offset from the outflow end portion of the frame along the longitudinal axis.

Example

[0087] The artificial heart valve according to any embodiment of the present specification, particularly the artificial heart valve described in Example 1, wherein each valve leaflet tab is wound circumferentially around a respective cross-linked support member.

Example

[0088] The artificial heart valve according to any embodiment of the present specification, particularly the artificial heart valve described in Example 1 or 2, wherein each valve leaflet tab forms a first fold extending radially outward from the main body of a respective valve leaflet, a second fold extending circumferentially along the inner surface of a respective cross-linked support member, and a third fold extending circumferentially along the outer surface of the cross-linked support member.

Example

[0089] The artificial heart valve according to any embodiment of the present specification, particularly the artificial heart valve described in Example 3, wherein the first fold of each pair of valve leaflet tabs extends through a respective opening of the frame.

Example

[0090] Each cusp tab is fixed to its respective commissural support member by one or more sutures extending through the second fold of the cusp tab, the commissural support member, and the third fold of the cusp tab, in any embodiment of the present specification, particularly the prosthetic heart valve described in Embodiment 3 or 4.

Example

[0091] Each commissural support body includes a plurality of holes through which one or more sutures extend, in any embodiment of the present specification, particularly the prosthetic heart valve described in Embodiment 5.

Example

[0092] Each cusp tab has an outflow edge axially displaced from the outflow edge of the main body of the cusp and an inflow edge axially displaced from the inflow edge of the main body of the cusp, in any embodiment of the present specification, particularly the prosthetic heart valve described in any one of Embodiments 1 to 6.

Example

[0093] Each commissural tab assembly is connected to the outer surface of the frame by one or more sutures, in any embodiment of the present specification, particularly the prosthetic heart valve described in any one of Embodiments 1 to 7.

Example

[0094] In each commissural tab assembly, the commissural support member has a height greater than the height of each frame opening through which a pair of cusp tabs extend, in any embodiment of the present specification, particularly the prosthetic heart valve described in any one of Embodiments 1 to 8.

Example

[0095] In each commissural tab assembly, the commissural support member has a width greater than the width of each frame opening through which a pair of cusp tabs extend, in any embodiment of the present specification, particularly the prosthetic heart valve described in any one of Embodiments 1 to 9.

Example

[0096] The opening of the frame is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 10, defined by a row of angled struts of the frame.

Example

[0097] The opening of the frame is arranged in a row extending in the circumferential direction of the opening, including a first row at the inflow end of the frame and a second row at the outflow end of the frame, which is an artificial heart valve according to any embodiment of the present specification, particularly Embodiment 11.

Example

[0098] In each row of the opening, the opening has the same size, which is an artificial heart valve according to any embodiment of the present specification, particularly Embodiment 12.

Example

[0099] Most of each opening in the second row is not covered by the valve leaflet when the valve leaflet is in the open position, which is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 12 to 13.

Example

[0100] The artificial heart valve further includes an outer skirt having a first end located at the inflow end of the frame and a second end located between the inflow end and the outflow end of the frame, and the outer skirt extends along the outer surface of the frame from the first end to the second end, which is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 14.

Example

[0101] The frame has a diameter of less than 23 mm and a height of 15 mm to 18 mm, which is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 15.

Example

[0102] The frame has a diameter of 20 mm or less and is an artificial heart valve according to any embodiment of the present specification, particularly Embodiment 16.

Example

[0103] The valve tip has a height of 11 mm or more and is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 17.

Example

[0104] The valve tip has a minimum height of 11 mm, and the frame has a diameter of 20 mm or less and a height of 15 mm to 18 mm, and is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 18.

Example

[0105] The frame has a ratio of diameter to height of about 1.24 to about 1.34 and is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 19.

Example

[0106] The diameter of the frame and the height of the valve tip have a ratio of diameter to height of about 1.61 to about 1.71 and are an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 20.

Example

[0107] The height of the frame and the height of the valve tip have a ratio of frame height to valve tip height of about 1.24 to about 1.34 and are an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 21.

Example

[0108] Each opening of the frame between the outflow edge of the valve tip and the outflow end of the frame has a maximum width of 2 mm or more and is an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 1 to 22.

Example

[0109] An artificial heart valve, comprising an annular frame having an inflow end, an outflow end, a plurality of openings, and a longitudinal axis; a plurality of cross-linked support members each having an outer surface and an inner surface; a plurality of valve leaflets each having a main body with an inflow edge and an outflow edge, and a pair of opposing valve leaflet tabs extending from both sides of the main body, each valve leaflet tab being paired with an adjacent valve leaflet tab of an adjacent valve leaflet, each pair of valve leaflet tabs extending through a respective opening of the frame and being connected to one of the cross-linked supports outside the frame to form a cross-linked tab assembly; each valve leaflet tab forming a first fold extending radially outward from the main body of the respective valve leaflet through the respective opening of the frame, a second fold extending circumferentially between the inner surface of the respective support member and the outer surface of the frame, and a third fold extending circumferentially along the outer surface of the support member.

Example

[0110] The valve leaflets are each configured to open under fluid pressure such that the outflow edge of the valve leaflet contacts the frame, according to any embodiment of the present specification, particularly the artificial heart valve described in Example 24.

Example

[0111] Each cross-linked support member includes a rectangular plate having flat and parallel inner and outer surfaces, according to any embodiment of the present specification, particularly the artificial heart valve described in Example 24 or 25.

Example

[0112] Each valve leaflet tab is fixed to the respective cross-linked support member by one or more sutures extending through the second fold of the valve leaflet tab, the cross-linked support member, and the third fold of the valve leaflet tab, according to any embodiment of the present specification, particularly any one of Examples 24 to 26.

Example

[0113] Each commissural support includes a plurality of holes through which one or more sutures extend, for any embodiment of the present specification, particularly the artificial heart valve described in Embodiment 27.

Example

[0114] In each commissural tab assembly, the commissural support member has a height greater than the height of each frame opening through which a pair of leaflet tabs extend, for any embodiment of the present specification, particularly any one of Embodiments 24 to 28 of the artificial heart valve described.

Example

[0115] Further includes an outer skirt having a first end located at the inflow end of the frame and a second end located between the inflow end and the outflow end of the frame, and the outer skirt extends along the outer surface of the frame from the first end to the second end, for any embodiment of the present specification, particularly any one of Embodiments 24 to 29 of the artificial heart valve described.

Example

[0116] The outer skirt partially covers the commissural tab assembly, for any embodiment of the present specification, particularly the artificial heart valve described in Embodiment 30.

Example

[0117] The inflow edge of the leaflet is connected to the inflow end of the frame by one or more sutures that extend through the leaflet and around the struts of the frame that define the inflow end of the frame, for any embodiment of the present specification, particularly any one of Embodiments 24 to 31 of the artificial heart valve described.

Example

[0118] The artificial heart valve has no fabric material inside the frame, for any embodiment of the present specification, particularly any one of Embodiments 24 to 32 of the artificial heart valve described.

Example

[0119] The cross-linked assembly includes an artificial heart valve according to any embodiment of this specification, particularly any one of Embodiments 24 to 33, without any fabric material.

Example

[0120] The outflow edge of the valve tip is axially displaced from the outflow end of the frame along the longitudinal axis, and is an artificial heart valve according to any embodiment of this specification, particularly any one of Embodiments 24 to 34.

Example

[0121] The openings of the frame form a circumferentially extending row of openings including a first row at the inflow end of the frame and a second row at the outflow end of the frame, and are arranged as an artificial heart valve according to any embodiment of this specification, particularly Embodiment 35.

Example

[0122] The outflow edge of the valve tip is perpendicular to the longitudinal axis and bisects the openings of the second row of the openings, and is located upstream of the plane, and is an artificial heart valve according to any embodiment of this specification, particularly Embodiment 36.

Example

[0123] The valve tip is in a quadrilateral shape and is an artificial heart valve according to any embodiment of this specification, particularly any one of Embodiments 24 to 37.

Example

[0124] Each valve tip is in a rectangular shape and has a width greater than the height, and is an artificial heart valve according to any embodiment of this specification, particularly Embodiment 38.

Example

[0125] An artificial heart valve, comprising an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of cross-linking support members outside the frame; and a plurality of valve leaflets, each valve leaflet having a main body having an inflow edge and an outflow edge, and a pair of opposing valve leaflet tabs extending from both sides of the main body, each valve leaflet tab being paired with an adjacent valve leaflet tab of an adjacent valve leaflet, each pair of valve leaflet tabs extending through a respective opening of the frame and being connected to one of the cross-linking supports to form a cross-linking tab assembly, each cross-linking tab assembly being located on the exterior of the frame and the main body of each valve leaflet being located on the interior of the frame; in each cross-linking tab assembly, the cross-linking support member has a height greater than the height of the respective frame opening through which the pair of valve leaflet tabs extends, artificial heart valve.

Example

[0126] Each valve leaflet tab forms a first fold extending radially outward from the main body of the respective valve leaflet, a second fold extending circumferentially along the inner surface of the respective cross-linking support member, and a third fold extending circumferentially along the outer surface of the cross-linking support member, the artificial heart valve according to any embodiment of the present specification, particularly embodiment 40.

Example

[0127] The first fold of each pair of valve leaflet tabs extends through a respective opening of the frame, the artificial heart valve according to any embodiment of the present specification, particularly embodiment 41.

Example

[0128] Each valve leaflet tab is fixed to the respective cross-linking support member by one or more sutures extending through the second fold of the valve leaflet tab, the cross-linking support member, and the third fold of the valve leaflet tab, the artificial heart valve according to any embodiment of the present specification, particularly embodiments 41 or 42.

Example

[0129] Each interconnected support includes a plurality of holes through which one or more sutures extend, for an artificial heart valve described in any embodiment of this specification, particularly embodiment 43.

Example

[0130] The inflow edge of the valve tip and the inflow end of the frame are aligned, and the outflow edge of the valve tip is axially displaced from the outflow end of the frame along the longitudinal axis, for an artificial heart valve described in any embodiment of this specification, particularly any one of embodiments 40 to 44.

Example

[0131] The frame includes a row of openings bounded by a row of struts of the frame that define the outlet end of the frame, and the outflow edge of the valve tip is upstream of most of each opening in the row, for an artificial heart valve described in any embodiment of this specification, particularly any one of embodiments 40 to 45.

Example

[0132] The frame has a diameter of less than 23 mm and a height of 15 mm to 18 mm, for an artificial heart valve described in any embodiment of this specification, particularly any one of embodiments 40 to 46.

Example

[0133] The frame has a diameter of 20 mm or less, for an artificial heart valve described in any embodiment of this specification, particularly embodiment 47.

Example

[0134] The valve tip has a height of 11 mm or more, for an artificial heart valve described in any embodiment of this specification, particularly any one of embodiments 40 to 48.

Example

[0135] The valve tip has a minimum height of 11 mm, and the frame has a diameter of 20 mm or less and a height of 15 mm to 18 mm, for an artificial heart valve described in any embodiment of this specification, particularly any one of embodiments 40 to 49.

Example

[0136] The valve leaflet is in the shape of a quadrilateral, and is an artificial heart valve described in any embodiment of this specification, particularly any one of Embodiments 40 to 50.

Example

[0137] Each valve leaflet is in the shape of a rectangle and has a width greater than its height, and is an artificial heart valve described in any embodiment of this specification, particularly Embodiment 51.

Example

[0138] A valve leaflet assembly for an artificial heart valve, comprising a plurality of valve leaflets, each valve leaflet including a main body having an inflow edge and an outflow edge, and opposing commissural tabs extending from both sides of the main body; and a plurality of commissural support members each having a pair of opposing faces; each commissural tab is paired with an adjacent commissural tab of an adjacent valve leaflet, and in each pair of commissural tabs, the commissural tab is partially wound around and connected to one of the opposing faces of the support member to form a commissural assembly.

Example

[0139] Each commissural tab forms a first fold extending radially outward from the main body of its respective valve leaflet, a second fold extending circumferentially along the inner surface of its respective commissural support member, and a third fold extending circumferentially along the outer surface of the commissural support member, and is an example of a valve leaflet assembly described in any embodiment of this specification, particularly Embodiment 53.

Example

[0140] Each commissural tab is fixed to its respective commissural support member by one or more sutures extending through the second fold of the commissural tab, the commissural support member, and the third fold of the commissural tab, and is an example of a valve leaflet assembly described in any embodiment of this specification, particularly Embodiment 54.

Example

[0141] Each cross-linked support includes a plurality of holes through which one or more sutures extend, such as the leaflet assembly described in any embodiment of this specification, particularly Embodiment 55.

Example

[0142] The holes are arranged in a two-column configuration, such as the leaflet assembly described in any embodiment of this specification, particularly Embodiment 56.

Example

[0143] The holes are in a single-column configuration, such as the leaflet assembly described in any embodiment of this specification, particularly Embodiment 56.

Example

[0144] The leaflets are made of separate pericardial pieces, such as the leaflet assembly described in any one of Embodiments 53 to 58 of this specification.

Example

[0145] The leaflets are sections of an integral pericardial piece, such as the leaflet assembly described in any one of Embodiments 53 to 58 of this specification.

Example

[0146] The leaflets are quadrilateral in shape, such as the leaflet assembly described in any one of Embodiments 53 to 60 of this specification.

Example

[0147] Each leaflet is rectangular in shape and has a width greater than its height, such as the leaflet assembly described in any one of Embodiments 61 of this specification.

Example

[0148] A method of assembling an artificial heart valve, comprising the steps of forming a leaflet assembly from a plurality of leaflets, each leaflet including opposing commissural tabs, the leaflet assembly pairing the commissural tabs of each leaflet with adjacent commissural tabs of adjacent leaflets and connecting each pair of commissural tabs to a commissural support member to form respective commissural assemblies of the leaflet assembly; positioning the leaflet assembly inside an expandable annular frame, the frame defining a plurality of openings; and inserting each of the commissural assemblies of the leaflet assembly through a respective opening of the frame and positioning the commissural assemblies outside the frame.

Example

[0149] The step of inserting each of the commissural assemblies of the leaflet assembly through a respective opening of the frame further includes deforming each of the commissural assemblies from a first position to a second position relative to the main body of the leaflet such that the commissural assemblies are in a deformed orientation at the second position; inserting each of the commissural assemblies at the second position through a respective opening of the frame such that each commissural support member is positioned completely outside the frame; and after inserting each commissural assembly through its respective opening, returning each of the commissural assemblies from the second position to the first position, according to any embodiment herein, particularly the method described in Embodiment 63.

Example

[0150] The step of positioning the leaflet assembly inside the frame further includes aligning the inflow edge of the leaflet assembly with the inflow end of the frame and positioning the outflow edge of the leaflet assembly between the inflow end and the outflow end of the frame, according to any embodiment herein, particularly the method described in Embodiment 63 or 64.

Example

[0151] The method according to any embodiment of the present specification, in particular embodiment 65, further comprising the step of sewing the inlet edge of the valve tip to the strut of the frame at the inlet end of the frame.

Example

[0152] The valve tip is of a quadrilateral shape, the method according to any embodiment of the present specification, in particular any one of embodiments 63 to 66.

Example

[0153] Each valve tip is of a rectangular shape and has a width greater than its height, the method according to any embodiment of the present specification, in particular embodiment 67.

Example

[0154] The step of connecting each pair of cross-linking tabs to a cross-linking support member to form respective cross-linking assemblies includes folding each cross-linking tab of the pair to form a first fold contacting the first side of the cross-linking support member and a second fold contacting the second side of the cross-linking support member; and sewing the first and second folds to the cross-linking support member, the method according to any embodiment of the present specification, in particular any one of embodiments 63 to 68.

Example

[0155] Each cross-linking support member has a dimension larger than the dimension of each frame opening through which the cross-linking support member is inserted, in order to prevent the cross-linking assembly from being pulled inward into the frame after the cross-linking assembly is positioned outside the frame, the method according to any embodiment of the present specification, in particular any one of embodiments 63 to 69.

[0156] It should be recognized that considering many possible embodiments to which the principles of the disclosed invention can be applied, the illustrated embodiments are merely preferred examples of the present invention and should not be understood as limiting the scope of the invention. Rather, the scope of the present invention is defined by the following claims. Accordingly, all that is included in the spirit and scope of these claims is claimed as the invention.

Description of Symbols

[0157] 100 Artificial heart valve 102 Frame 104 First end 104 Inflow end 106 Second end 106 Outflow end 108 Inner surface 110 Outer surface 112 Lattice strut 114 Top 116 Top 118 Longitudinal axis 120 Open frame opening 122 Valve structure 124 Valve tip 126 Crosslink 126 Valve tip contact area 128 Crosslink support member 128' Support member 128'' Support member 130 Crosslink tab assembly 132 Inflow edge 134 Outflow edge 134 Outflow end 138 Diameter 143 Main body 144 Valve tip tab 144a Valve tip tab 144a Fold 144b Valve tip tab 144b Fold 144c Fold 146 Side 148 Suture 150 Hole 152 Suture 154 Outer skirt 160 Suture 162 Outflow edge 164 Inflow edge 166 Inner surface 168 Outer surface 224 Valve structure 224a Valve tip 224b valve tip 224c valve tip 232 inlet edge 234 outlet edge 243a main body 243b main body 243c main body 244a outermost tab 244b intermediate valve tip tab 244c intermediate valve tip tab 244d outermost tab 324 valve tip 332 inlet edge 334 outlet edge 344a valve tip tab 344b valve tip tab 424 valve structure 424a valve tip 424b valve tip 424c valve tip 432 inlet edge 434 outlet edge 443a main body 443b main body 443c main body 444a outermost tab 444b intermediate valve tip tab 444c intermediate valve tip tab 444d outermost tab 500 delivery device 502 handle 504 outer shaft 506 intermediate shaft 508 inner shaft 510 proximal end portion 512 adapter 514 rotatable knob 518 inflatable balloon 520 central longitudinal axis 522 nose cone 524 valve mounting portion 526 distal shoulder 528 distal tip portion 538 first port 540 Second Port 550 Artificial Heart Valve 560 Rotatable Knob 561 Adjustment Mechanism 562 Rotatable Knob 578 Rotatable Knob D Diameter H1 Valve Tip Height H2 Height H3 Height L1 Length L2 Length L3 Length L4 Height P Plane W1 Width W2 Width W3 Width W4 Maximum Width

Claims

1. An artificial heart valve (100) comprising: an expandable annular frame (102) having an inflow end (104), an outflow end (106), an interior (108), an exterior (110), a plurality of openings (120), and a longitudinal axis (118); a plurality of cross-linking support members (128) on the outer side of the frame (102); a plurality of valve leaflets (124); wherein each of the plurality of valve leaflets (124) has a main body (143) having an inflow edge (132) and an outflow edge (134), and a pair of opposing valve leaflet tabs (144) extending from both sides of the main body (143); each valve leaflet tab (144) is paired with an adjacent valve leaflet tab (144) of an adjacent valve leaflet (124); each pair of valve leaflet tabs (144) is configured to extend through a respective opening (120) of the frame (102) and is connected to one of the cross-linking support members (128) to form a cross-linking tab assembly (130) pre-assembled before the valve leaflets (124) are disposed inside the frame (102); each cross-linking tab assembly (130) is located on the exterior (110) of the frame (102), and the main body (143) of each valve leaflet (124) is located on the interior (108) of the frame (102); in each cross-linking tab assembly (130), the cross-linking support member (128) has a height higher than the height (H2) of a respective frame opening (120) through which the pair of opposing valve leaflet tabs (144) extend, the artificial heart valve (100).

2. Each valve leaflet tab (144) is wound circumferentially around a respective cross-linking support member (128), the artificial heart valve (100) according to claim 1.

3. Each valve leaflet tab (144) forms a first fold (144a) extending radially outward from the main body (143) of a respective valve leaflet (124), a second fold (144b) extending circumferentially along the inner surface of a respective cross-linking support member (128), and a third fold (144c) extending circumferentially along the outer surface of the cross-linking support member (128), the artificial heart valve (100) according to claim 1 or 2.

4. The first fold (144a) of each pair of valve leaflet tabs (144) extends through a respective opening (120) of the frame (102), the artificial heart valve (100) according to claim 3.

5. Each leaflet tab (144) is fixed to a respective cross-link support member (128) by one or more sutures (148) extending through the second fold (144b) of the leaflet tab (144), the cross-link support member (128), and the third fold (144c) of the leaflet tab (144), the artificial heart valve (100) according to claim 3 or 4.

6. Each leaflet tab (144) has an outflow edge (162) axially displaced from the outflow edge (134) of the main body (143) of the leaflet (124) and an inflow edge (164) axially displaced from the inflow edge (132) of the main body (143) of the leaflet (124), or The inflow edge (132) of the leaflet (124) and the inflow end (104) of the frame (102) are aligned, and the outflow edge (134) of the leaflet (124) is axially displaced from the outflow end (106) of the frame (102) along the longitudinal axis (118), the artificial heart valve (100) according to any one of claims 1 to 5.

7. Each cross-link tab assembly (130) is connected to the outer surface (110) of the frame (102) by one or more sutures (152), the artificial heart valve (100) according to any one of claims 1 to 6.

8. In each cross-link tab assembly (130), the cross-link support member (128) has a width (W2) greater than the width (W3) of each frame opening (120) through which the pair of opposing leaflet tabs (144) extend, the artificial heart valve (100) according to any one of claims 1 to 7.

9. The openings (120) of the frame (102) are arranged in a circumferentially extending row including a first row at the inflow end (104) of the frame (102) and a second row at the outflow end (106) of the frame (102), the artificial heart valve (100) according to any one of claims 1 to 8.

10. Each cross-link support member (128) includes a rectangular plate having flat and parallel inner surfaces (166) and outer surfaces (168), the artificial heart valve according to any one of claims 1 to 9.

11. A method of assembling an artificial heart valve (100), comprising Forming a valve tip assembly from a plurality of valve tips (124), each valve tip (124) including opposing interlocking tabs (144), the valve tip assembly being formed by pairing the interlocking tabs (144) of each valve tip (124) with adjacent interlocking tabs (144) of adjacent valve tips (124) and connecting each pair of interlocking tabs (144) to an interlocking support member (128) to form respective interlocking assemblies of the valve tip assembly. Positioning the valve tip assembly within an interior (108) of an expandable annular frame (102), the frame (102) defining a plurality of openings (120). Inserting each of the interlocking assemblies of the valve tip assembly through a respective opening (120) of the frame (102) and positioning the interlocking assemblies on an exterior (110) of the frame (102). A method comprising.

12. The step of inserting each of the interlocking assemblies of the valve tip assembly through a respective opening (120) of the frame (102) comprises Deforming each of the interlocking assemblies from a first position to a second position relative to a main body (143) of the valve tip (124) such that the interlocking assemblies are in a deformed orientation at the second position. Inserting each of the interlocking assemblies at the second position through a respective opening (120) of the frame (102) such that each interlocking support member (128) is fully positioned on the exterior (110) of the frame (102). After inserting each interlocking assembly through a respective opening (120), returning each of the interlocking assemblies from the second position to the first position. The method according to claim 11, further comprising.

13. The step of positioning the valve tip assembly within the interior (108) of the frame (102) comprises Aligning an inlet edge (132) of the valve tip assembly with an inlet end (104) of the frame (102). Positioning an outlet edge (134) of the valve tip assembly between the inlet end (104) and an outlet end (106) of the frame (102). The method according to claim 11 or 12, further comprising. The method according to claim 13, further comprising the step of sewing the inlet edge (132) of the valve tip (124) to the support column (112) of the frame (102) at the inlet end (104) of the frame (102).

15. The method according to any one of claims 11 to 14, wherein the valve tip (124) has a quadrilateral shape.

16. The step of connecting each pair of cross-linking tabs (144) to the cross-linking support member (128) to form respective cross-linking assemblies comprises folding each of the pair of cross-linking tabs (144) to form a first fold (144a) in contact with a first side of the cross-linking support member (128) and a second fold (144b) in contact with a second side of the cross-linking support member (128); and sewing the first fold (144a) and the second fold (144b) to the cross-linking support member (128). The method according to any one of claims 11 to 15.

17. Each cross-linking support member (128) has a dimension larger than the dimension of each frame opening (120) through which the cross-linking support member (128) is inserted, in order to prevent the cross-linking assembly from being pulled inwardly into the frame (102) after the cross-linking assembly is positioned outside the frame (102). The method according to any one of claims 11 to 16.

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