Method for assembling a valve leaflet commissure assembly and a prosthetic heart valve

Abstract

A prosthetic heart valve is disclosed that includes an annular frame and a plurality of leaflets. The annular frame is disposed between the outflow and inflow ends of the frame and includes interconnected struts defining a plurality of rows of cells, including an upper row of cells at the outflow end. The frame further includes a plurality of commissural windows formed between the axially extending window struts of the frame, each having a commissural receiving portion disposed between the axially extending window struts of two adjacent cells and spaced from the upper ends of the two adjacent cells, and an open end. Each leaflet includes opposing commissural tabs that mate with adjacent commissural tabs of an adjacent leaflet to form a commissure, each commissure disposed within the commissural receiving portion of its respective commissural window, the open end of the commissural window configured to receive the commissure.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 003,085, filed Mar. 31, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] This disclosure relates to a prosthetic heart valve comprising a frame having a series of elongated cells, and methods and assemblies for forming commissures between the leaflets of such prosthetic heart valves.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can lead to severe 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, and several known methods for implanting these devices and valves into humans. Percutaneous and minimally invasive surgical techniques are used in various procedures to deliver prosthetic medical devices to locations in the body that are not easily accessible surgically or where access without surgery is desirable. In one particular example, a prosthetic heart valve can be mounted in a collapsed state at the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve can then be expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted and actuating a mechanical actuator that applies an expanding force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device such that the prosthetic valve can self - expand to its functional size.

[0004] A prosthetic valve that relies on a mechanical actuator for expansion can be called a “mechanically expandable” prosthetic heart valve. The actuator typically takes the form of a tension cable, suture, wire, and / or shaft configured to transmit the expansion force from the delivery device handle to the prosthetic valve.

[0005] Most expandable diameter catheter heart valves comprise a cylindrical metal frame or stent and prosthetic leaflets mounted within the frame. The leaflets can be attached to the frame at their commissure tabs. For example, a commissure is formed by connecting the commissure tabs of two adjacent leaflets to a flexible sheet or attachment member configured to connect them to each other and, in some embodiments, to a commissure support portion of the frame. Thus, the commissure can be attached to the commissure support portion of the frame via fasteners such as sutures.

[0006] Diameter catheter heart valves have traditionally been used for moderate to high dilation diameters, such as in the range of 23–29 mm. Smaller diameter valves, such as 20 mm prosthetic valves, are used less frequently due to various difficulties arising from the smaller size of the cells in the frame. For example, the smaller cells in such frames may interfere with blood flow to the coronary artery ostia after valve-in-valve (e.g., prosthetic valve-in-prosthetic valve) procedures. Another example is that smaller cells may prevent passage of cells in optional coronary reaccess devices after valve implantation.

[0007] To address these issues at least partially, the upper row of cells in a prosthetic valve frame, positioned close to the outflow end of the frame, can be elongated relative to the other rows of cells in the frame. However, the leaflet assemblies of the prosthetic valve, including the commissures attached to the frame, can at least partially obstruct the opening of the upper row of cells, thereby reducing access to blood flow and coronary reaccess devices. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 6,730,118 [Patent Document 2] WIPO Patent Application Publication No. WO2018 / 222799 [Patent Document 3] U.S. Patent No. 9,339,384 [Patent Document 4] U.S. Provisional Patent Application No. 63 / 069,567 [Patent Document 5] U.S. Provisional Patent Application No. 63 / 138,890 [Overview of the project] [Problems that the invention aims to solve]

[0009] Therefore, there is a need for improved prosthetic heart valves and improved commissure attachment assemblies that hold the leaflets of the prosthetic valve in a lower position within the frame. This lower position allows for the maintenance of a relatively open cell region within the upper cell adjacent to the outflow end of the frame, thereby allowing increased blood flow to the coronary orifice and passage of coronary reaccess devices once the prosthetic valve is implanted. [Means for solving the problem]

[0010] Described herein are embodiments of a prosthetic heart valve and embodiments of a method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly. In some embodiments, at least partially pre-assembled commisses, each comprising a pair of adjacent leaflet commissure tabs of the leaflet assembly, may be positioned within an annular frame commissure window or within a commissure support element configured to be coupled to a portion of the annular frame configured to receive a commissure support element. The commissure window, the portion of the annular frame configured to receive a commissure support element, and / or the commissure support element may be configured to position the commisses within the lower portion of an elongated cell above the annular frame.

[0011] In one representative embodiment, a method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly includes the step of inserting a commissure, pre-assembled outside the annular frame, into a commissure window of the frame through an opening in the upper or lower portion of the commissure window, wherein the commissure comprises a pair of commissure tabs fixed integrally to adjacent leaflets of the leaflet assembly, and each commissure window is formed by one or more axially extending supports of two adjacent cells in an upper row of cells of the frame, the upper row of cells being located at the outflow end of the frame and having an elongated length axially with respect to the central longitudinal axis of the frame with respect to the cells in the remaining rows of cells of the frame. The method further includes the step of securing the commissure in a commissure receiving portion of the commissure window via one or more fasteners such that the commissure is located in the lower portion of the upper row of cells and an open area unobstructed from the leaflets is formed in the upper portion of the upper row of cells, the upper portion being located closer to the outflow end than the lower portion.

[0012] In another representative embodiment, the prosthetic heart valve comprises an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows being located between the outflow end and the inflow end of the frame, and including an upper row of cells located at the outflow end and a lower row of cells located at the inflow end. The annular frame further comprises a plurality of commissure windows formed between window struts extending axially of the frame, each commissure window being located between window struts extending axially of two adjacent cells in the upper row of open cells, and each commissure window having a commissure receiving portion spaced apart from the upper ends of the two adjacent cells, the upper end of which is located at the outflow end of the frame, and an open end. The prosthetic heart valve further comprises a leaflet assembly having multiple leaflets, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, each commissure being positioned within the commissure receiving portion of its respective commissure window, and the open end of the commissure window being configured to receive the commissure through the open end.

[0013] In one embodiment, the cells in the upper column of a cell are elongated in the axial direction with respect to the central longitudinal axis of the frame, with respect to the cells in the remaining columns of the cell among the multiple columns of the cell, including the lower column of the cell.

[0014] In another representative embodiment, the prosthetic heart valve comprises an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells being axially elongated relative to the cells of the remaining rows of cells of the plurality of rows of cells, located between the outflow and inflow ends of the frame, and including an upper row of cells located at the outflow end, the axial direction being relative to the central longitudinal axis of the frame. The prosthetic heart valve further comprises a plurality of leaflets located within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure. The struts defining the upper row of cells are open at the upper end and further define a plurality of open commissure windows formed between adjacent elongated cells of the upper row of cells, each commissure window being formed between two axially elongated window struts spaced apart from each other in the circumferential direction, each commissure window comprising a lower region configured to receive the commissure tab of the commissure and an upper region located at the outflow end of the frame.

[0015] In another representative embodiment, the prosthetic heart valve comprises an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows being positioned between the outflow and inflow ends of the frame and being axially elongated with respect to the cells of the remaining rows of cells of the plurality of rows of cells, including the upper row of cells positioned at the outflow end, and the axial direction with respect to the central longitudinal axis of the frame. The prosthetic heart valve further comprises a plurality of leaflets located within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, and each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure. The struts defining the upper row of cells are open at their lower ends, further defining a number of open commissar windows formed between adjacent elongated cells in the upper row of cells within the lower portion of adjacent elongated cells, each commissar window being formed by two axially extending window struts spaced apart in the circumferential direction, each configured to receive a commissar inside, the two axially extending window struts being connected to an upper axial strut via the upper edge of the commissar window, and to a lower oblique strut of the upper row of cells, the upper axial strut and the two axially extending window struts together forming axially extending struts defining the axial sides of each of two adjacent elongated cells.

[0016] In another representative embodiment, the prosthetic heart valve comprises an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells being positioned between the outflow and inflow ends of the frame and being axially elongated relative to the cells of the remaining rows of cells of the plurality of rows of cells, including the upper row of cells positioned at the outflow end, and the axial direction relative to the central longitudinal axis of the frame. The prosthetic heart valve further comprises a plurality of leaflets located within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, and each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure. A column defining the upper row of cells further defines a plurality of open commissar windows, each commissar window being open at its upper end and formed between two adjacent elongated cells in the lower portion of two adjacent elongated cells in the upper row of cells, each commissar window being divided into a first commissar portion and a second commissar portion, each of the first and second commissar portions being configured to receive different commissar tabs of the commissar, the first commissar portion being formed between a central axially extending column and a first axial support arm connected to the axially extending column and laterally offset from the axially extending column in the circumferential direction relative to the periphery of the frame, the second commissar portion being formed between an axially extending column and a second axial support arm connected to the axially extending column and laterally offset from the axially extending column.

[0017] In another representative embodiment, the prosthetic heart valve comprises an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells being positioned between the outflow end and the inflow end of the frame, and including an upper row of cells positioned at the outflow end and a lower row of cells positioned at the inflow end, the cells of the upper row of cells being elongated axially with respect to the central longitudinal axis of the frame, with respect to the cells of the remaining rows of cells among the plurality of rows of cells, including the lower row of cells. The annular frame further comprises several commissure windows, each commissure window defined by a closed frame, the closed frame comprising a wider first portion and a narrower second portion, the first portion connected to an upper elongated strut joint of the frame via a bendable strut portion, the upper elongated strut joint being the joint between two oblique struts of two adjacent elongated cells in the upper row of cells, the axially extending struts positioned between two adjacent elongated cells, and the commissure window is configured to bend via its bendable strut portion from an extended configuration to a bent configuration in which the commissure window overlaps the axially extending strut. The prosthetic heart valve further comprises a leaflet assembly comprising several leaflets, each leaflet comprising a commissure tab opposite to the opposite side of the leaflet, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, and each commissure positioned within the respective second portion of its respective commissure window.

[0018] In another representative embodiment, a method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly includes the step of bending the commissure window of the annular frame into a first bent configuration between a fully extended configuration and a fully bent configuration, wherein the commissure window is defined by a closed strut frame comprising a wider first portion and a narrower second portion, the first portion being connected via a bendable strut portion to an upper elongated strut joint of the annular frame, the upper elongated strut joint being a joint between two oblique struts of two adjacent elongated cells in an upper row of elongated cells located at the outflow end of the annular frame, the axially extending struts being located between two adjacent elongated cells, and in the fully extended configuration, the bendable strut portion is not bent, the commissure window extends outward from the outflow end of the annular frame in the axial direction with respect to the central longitudinal axis of the annular frame, and in the fully bent configuration, the commissure window overlaps the axially extending struts. The method further includes the step of inserting a commissure, at least partially pre-assembled outside an annular frame, into a commissure window, the commissure comprising a pair of commissure tabs fixed integrally to adjacently positioned leaflets of a leaflet assembly. The method further includes the step of bending the commissure window into a fully bent configuration such that the commissure window extends parallel to an axially extending support and is positioned radially inward of the axially extending support, and the step of fixing the commissure window in the fully bent configuration to an annular frame.

[0019] In another representative embodiment, a method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly includes the step of inserting a commissure, at least partially pre-assembled outside the annular frame, into a leaflet receiving window through an opening in the leaflet receiving window of a commissure support element, the commissure comprising a pair of commissure tabs fixed integrally to adjacent leaflets of the leaflet assembly, the leaflet receiving window being open at a first end and formed by at least a portion of two axially extending members of a commissure support element connected at the opposite second end by a connecting member, the commissure support element comprising a connecting portion adapted to connect to a portion of the annular frame forming two adjacent cells in an upper row of cells of the annular frame, the upper row of cells being located at the outflow end of the annular frame and having an elongated length in the axial direction with respect to the central longitudinal axis of the annular frame with respect to the cells in the remaining row of cells of the annular frame. The method further includes the step of attaching a commissure support element to a portion of an annular frame such that a leaflet receiving window and a commissure positioned therein are located within the lower portion of the upper row of cells, and an open area unobstructed by the leaflets is formed within the upper portion of the upper row of cells.

[0020] In another representative embodiment, the prosthetic heart valve is an annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells including an upper row of cells located at the outflow end, which is positioned between the outflow and inflow ends of the frame and is axially elongated with respect to the cells of the remaining rows of cells of the plurality of rows of cells, and a plurality of leaflets located within the frame, each leaflet comprising a plurality of leaflets, each leaflet comprising a commissure tab facing the opposite side of the leaflet, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, and at least one commissure support element comprising a joint portion and two axially elongated members radially offset from the joint portion and spaced laterally apart from each other to form an open leaflet receiving window configured to receive a commissure, the joint portion being configured to join to the upper edges of two adjacent cells in the upper row of cells, the upper edges being positioned at the outflow end of the frame, and the leaflet receiving window being spaced axially apart from the upper edges.

[0021] In other representative embodiments, the prosthetic heart valve is an annular frame comprising a plurality of interconnected struts defining a plurality of columns of cells, the plurality of columns being disposed between an outflow end and an inflow end of the frame, and including an upper column of cells disposed at the outflow end that is axially elongated relative to cells of the remaining columns of cells, the axial direction being with respect to the central longitudinal axis of the frame, the annular frame comprising a plurality of axial struts defining the upper column of cells, each axial strut forming a common axial side of two adjacent cells of the upper column of cells, a portion of the plurality of axial struts being window axial struts, each window axial strut comprising a closed strut window positioned at a distance from an upper end of the window axial strut along the length of the window axial strut. The prosthetic heart valve further comprises a plurality of valve leaflets positioned within the frame, each valve leaflet comprising cross-link tabs opposite each other on opposite sides of the valve leaflet, each cross-link tab being paired with an adjacent cross-link tab of an adjacent valve leaflet to form a cross-link, and at least one cross-link support element comprising a coupling portion and two axially extending members laterally spaced from each other to form an open valve leaflet receiving window configured to receive a cross-link and radially offset from the coupling portion. The coupling portion is configured to couple to the strut window.

[0022] In other representative embodiments, the prosthetic heart valve is an annular frame comprising a plurality of interconnected struts defining a plurality of columns of cells, the plurality of columns being disposed between an outflow end and an inflow end of the frame and including an upper column of cells disposed at the outflow end, the annular frame, and a plurality of valve leaflets positioned within the frame, each valve leaflet comprising cross-link tabs opposite each other on opposite sides of the valve leaflet, each cross-link tab being paired with an adjacent cross-link tab of an adjacent valve leaflet to form a cross-link. The struts defining the upper column of cells further define a plurality of open cross-link windows formed between adjacent cells of the upper column of cells, each cross-link window being configured to receive a cross-link therein and formed by two axially extending window struts spaced from each other circumferentially, and the cross-link windows being axially offset toward the upstream end / inflow end of the upper column of cells.

[0023] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

[0024] [Figure 1] A perspective view of a prosthetic heart valve according to one embodiment. [Figure 2] A perspective view of an exemplary frame of a prosthetic heart valve. [Figure 3] A side view of the frame of FIG. 2 shown in a flat configuration. [Figure 4] A detailed view of a portion of the frame of FIG. 3 in which a pair of valve leaflets is disposed in a window of the frame. [Figure 5] A detailed view of a portion of a frame of a prosthetic heart valve having an open commissural window according to one embodiment. [Figure 6] A perspective view of an exemplary window fastener configured to be disposed within a portion of the open commissural window of FIG. 5. [Figure 7] A top view of the window fastener of FIG. 6 disposed within the open commissural window of FIG. 5. [Figure 8] A detailed view of a portion of a frame of a prosthetic heart valve having an open commissural window according to other embodiments. [Figure 9] A detailed view of a portion of the frame of FIG. 8 in which a commissure is disposed within the open commissural window. [Figure 10] A detailed view of a portion of a frame of a prosthetic heart valve having an open commissural window according to other embodiments. [Figure 11] A detailed view of a portion of the frame of FIG. 10 in which a commissural tab is disposed within the open window portion of the open commissural window. [Figure 12] A view of a portion of an exemplary valve leaflet including an axially extending portion configured to be disposed within a portion of the open commissural window of FIG. 10. [Figure 13] A cross-sectional view from above of an embodiment of a commissure disposed within the open commissural window of FIG. 10. [Figure 14]This is a cross-sectional view from above of another embodiment of the cross joint located within the open cross joint window in Figure 10. [Figure 15] This is a detailed view of a portion of the frame of a prosthetic heart valve with a bendable commissure window according to an embodiment. [Figure 16] Figure 15 is a detailed view of a portion of the frame, in which the crossbar window is bent along a support column extending in the axial direction of the frame, and the crossbar is positioned within the crossbar window. [Figure 17] This is a flowchart illustrating a method for assembling the commissure within the bendable commissure window of the prosthetic heart valve frame and fixing the bendable commissure window, including the commissure, to the frame. [Figure 18] This is a diagram illustrating an exemplary embodiment of a commissure support element, which is coupled to the frame of a prosthetic heart valve and configured to receive the commissure into the leaflet receiving window of the commissure support element. [Figure 19] Figure 18 is a detailed view of a portion of the frame of a prosthetic heart valve, where the commissure support elements are connected to the upper row of elongated cells in the frame. [Figure 20] Figure 18 shows the commissar within the commissar support element, and Figure 19 shows the commissar support element connected to the frame. [Figure 21] Figure 18 shows a cross-support element connected to the upper row of elongated cells of the frame in Figure 19, radially inward of the axial support of the frame, which has a wider width than the other axial supports of the frame. [Figure 22] This is a detailed view of a portion of the frame of a prosthetic heart valve, which has an axial support column configured such that the support window receives a commissure support element. [Figure 23] This is a detailed view of a portion of the frame in Figure 22, where the example cross-linked support element is connected to the support window. [Figure 24] Figure 22 is a detailed view of a portion of the frame, in which an exemplary commissure support element is connected to a support window, and the commissure is positioned within the valve leaflet receiving window of the commissure support element. [Figure 25] This is a side view of an embodiment of a delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site. [Modes for carrying out the invention]

[0025] General points to note For the purposes described herein, specific aspects, advantages, and novel features of embodiments of the disclosure are described herein. The methods, systems, and apparatus described herein should not be construed as limitations in any way. Rather, this disclosure is directed toward all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and subordinate combinations of each other. The disclosed methods, systems, and apparatus are not limited to specific aspects, features, or combinations thereof, and the disclosed methods, systems, and apparatus do not require that one or more specific advantages exist or that a problem is solved.

[0026] Any features, integers, properties, compounds, chemical parts, or groups described in conjunction with any specific aspects, embodiments, or examples of this disclosure will be understood to be applicable to any other aspects, embodiments, or examples described herein, insofar as they do not conflict. All features disclosed in this specification (including the attached claims, abstract, and drawings) and / or all of any methods or steps of processing so as to be disclosed may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. This disclosure is not limited to the details of the embodiments described above. This disclosure extends to any novel features or any novel combination of any features disclosed in this specification (including the attached claims, abstract, and drawings) or to any novel methods or steps of processing so as to be disclosed.

[0027] While some operations of the disclosed methods are described in a specific sequential order for the sake of convenient presentation, it should be understood that this description method encompasses rearrangement where a specific order is not required by explicit language stated later. For example, operations described sequentially may, in some cases, be rearranged or performed in parallel. Furthermore, for the sake of simplification, the accompanying figures may not illustrate the various ways in which the disclosed methods, systems, and apparatus can be used in combination with other systems, methods, and apparatus.

[0028] As used herein, the terms “a, an” and “at least one” encompass one or more specified elements. That is, if there are two specific elements, then one of those elements is also present, and therefore there is “an” element. The terms “a plurality of” and “plural” mean two or more specified elements.

[0029] As used herein, the term "and / or" used between at least the last two elements in a list means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0030] As used herein, the term “joining” generally means being physically joined or connected, and does not preclude the existence of intermediate elements between joined items, even without a clear opposite term.

[0031] Directions and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate the examination of the drawings and principles herein and are not intended to be limiting. For example, specific terms such as “inside,” “outside,” “up,” “down,” “internal,” and “external” may be used. Such terms are used, where applicable, specifically to provide some clarity when dealing with relative relationships with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, a “upper” part with respect to an object can become a “lower” part simply by turning the object upside down. Yet it is still the same part, and the object remains the same. As used herein, “and / or” means “and” and “or,” in addition to “and” or “or.”

[0032] In the context of this application, the terms “downward” and “upward” are used interchangeably with the terms “inflow” and “outflow,” respectively. Therefore, for example, the lower end of a valve is its inflow end, and the upper end of a valve is its outflow end.

[0033] As used herein, with respect to prosthetic heart valves and delivery devices, “proximal” refers to the location, orientation, or portion of a component of the delivery device that is outside the subject and closer to the user and / or handle, while “distal” refers to the location, orientation, or portion of a component that is further away from the user and / or handle of the delivery device and closer to the implantation site. The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined. Furthermore, the term “radial” refers to a direction along the radius from the center of an object, positioned perpendicular to axes and points (axes are centrally located, such as the longitudinal axis of a prosthetic valve).

[0034] Examples of disclosed technologies This specification describes examples of prosthetic heart valves and examples of methods for assembling prosthetic heart valves comprising an annular frame and a plurality of leaflets. A prosthetic heart valve may comprise an annular frame and a plurality of leaflets attached to the frame via commissures formed by connecting pairs of adjacent ends of leaflets (e.g., commistical tabs). In some embodiments, the commissures may be formed at least partially on the outside of the annular frame.

[0035] In one embodiment, the annular frame of the prosthetic heart valve may include multiple rows of cells formed by interconnected struts of the frame. The multiple rows of cells may include an upper row of cells (for example, located at the outflow end of the frame). In one embodiment, the cells of the upper row of cells are axially elongated relative to the cells of the remaining rows of cells in the frame.

[0036] In one embodiment, a portion of the support column of an annular frame forming the axial side of two adjacent elongated cells in the upper row of cells can form a commissar window adapted to receive the commissar and position the commissar within the lower region of the two adjacent elongated cells (for example, within a region located further away from the outflow end of the frame). In one embodiment, the frame may be configured such that the commissar window is axially offset toward the inflow end (for example, the upstream end) of the cells in the upper row of cells.

[0037] In other embodiments, a portion of the support column of an annular frame forming the axial side of two adjacent elongated cells in the upper row of cells can be adapted to receive a commissar support element, and the commissar support element is adapted to receive a commissar. Alternatively, a portion of the support column and / or the commissar support element can be adapted to position the commissar within the lower region of the two adjacent elongated cells.

[0038] In this method, the commissure and its associated valve leaflets can be positioned within the lower region of the upper column of the cell (for example, offset from the outflow end to the inflow end of the frame), thereby leaving a relatively open space within the upper region of the upper column of the cell, close to the outflow end of the frame. This relatively open space can provide increased blood flow through the valve and / or allow passage for a reaccess device, as described herein.

[0039] Figure 1 shows a prosthetic heart valve 10 according to one embodiment. The illustrated prosthetic valve is fitted to be implanted in a natural aortic annulus, but in other embodiments it can be fitted to be implanted in other natural annulus of the heart (e.g., the pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may be fitted to be implanted in other tubular organs or passages in the body. The prosthetic valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalve outer sealing member or outer skirt 18. The prosthetic valve 10 may have an inlet portion 15, an intermediate portion 17, and an outlet portion 19.

[0040] The valve structure 14 may comprise three leaflets 40 that collectively form a leaflet structure, the leaflet structure may be arranged to collapse in a tricuspid valve configuration, but in other embodiments there may be more or fewer leaflets (e.g., one or more leaflets 40). The leaflets 40 may be fixed to each other on their adjacent sides to form a commissure 22 of the leaflet structure 14. The lower edge of the valve structure 14 may have a undulating, curved wavy shape and may be fixed to the inner skirt 16 by sutures (not shown). In some embodiments, the leaflets 40 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or a variety of other suitable natural or synthetic materials, such as those technically known and incorporated herein by reference, as described in U.S. Patent No. 6,730,118.

[0041] The frame 12 may be formed with a plurality of circumferentially spaced slots or commissure windows 20 adapted to mount the commissures 22 of the valve structure 14 onto the frame. The frame 12 may be made from 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), as is known in the art. If constructed from a plastically expandable material, the frame 12 (and by extension, the prosthetic valve 10) can be compressed into a radially flattened configuration in a delivery catheter or delivery device and expanded inside the subject by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expanding material, the frame 12 (and by extension, the prosthetic valve 10) can be compressed into a radially flattened configuration and constrained in the compressed configuration by insertion into the sheath of a delivery catheter or equivalent mechanism. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, thereby expanding the prosthetic valve to its functional size.

[0042] Suitable plastically expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys, or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In specific embodiments, the frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (as dealt with by ASTM F562-02). MP35N® alloy / UNS R30035 alloy contains, by weight, 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum. Additional details relating to the prosthetic valve 10 and its various components are described in WIPO Patent Application Publication WO2018 / 222799, which is incorporated herein by reference.

[0043] Figure 25 shows an embodiment of a delivery device 800 that may be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 10 in Figure 1, or any of the other prosthetic heart valves described herein). In one embodiment, the delivery device 800 is specifically adapted for use when introducing the prosthetic valve into the heart.

[0044] The delivery device 800 in the embodiment illustrated in Figure 25 is a balloon catheter comprising a handle 802 and a maneuverable outer shaft 804 extending distally from the handle 802. The delivery device 800 may further comprise an intermediate shaft 806 (which may also be called a balloon shaft) extending proximal and distally from the handle 802, the portion of which extends distally from the handle 802 also extends coaxially through the outer shaft 804. The delivery device 800 may further comprise an inner shaft 808 extending coaxially distally from the handle 802 through the intermediate shaft 806 and the outer shaft 804, and proximal from the handle 802 through the intermediate shaft 806.

[0045] The outer shaft 804 and the intermediate shaft 806 may be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 820 of the delivery device 800 in order to facilitate the delivery and positioning of the prosthetic flap at the implantation site in the subject.

[0046] The intermediate shaft 806 may include a proximal end portion 810 that extends proximal to the adapter 812 from the proximal end of the handle 802. A rotatable knob 814 may be mounted on the proximal end portion 810 and configured to rotate the intermediate shaft 806 around the central longitudinal axis 820 relative to the outer shaft 804.

[0047] The adapter 812 may include a first port 838 configured to receive a guide wire through it, and a second port 840 configured to receive fluid (e.g., expansion fluid) from a fluid supply source. The second port 840 may be fluid-coupled to the inner lumen of the intermediate shaft 806.

[0048] The intermediate shaft 806 may further include a distal end portion that extends distally beyond the distal end of the outer shaft 804 when the distal end of the outer shaft 804 is positioned away from the inflatable balloon 818 of the delivery device 800. The distal end portion of the inner shaft 808 may extend distally beyond the distal end portion of the intermediate shaft 806.

[0049] Balloon 818 can be connected to the distal end portion of the intermediate shaft 806.

[0050] In one embodiment, the distal end of the balloon 818 may be coupled to the distal end of the delivery device 800, such as to a nose cone 822 (as shown in Figure 25) or to an alternative component at the distal end of the delivery device 800 (e.g., the distal shoulder). The middle portion of the balloon 818 may cover the valve mounting portion 824 of the distal end portion of the delivery device 800, and the distal end portion of the balloon 818 may cover the distal shoulder portion 826 of the delivery device 800. The valve mounting portion 824 and the middle portion of the balloon 818 may be configured to receive a prosthetic heart valve in a radially compressed state. For example, as schematically shown in Figure 25, a prosthetic heart valve 850 (which may be one of the prosthetic valves described herein) may be mounted around the balloon 818 at the valve mounting portion 824 of the delivery device 800.

[0051] The balloon shoulder assembly, including the distal shoulder portion 826, is configured to maintain the prosthetic heart valve 850 (or other medical device) in a fixed position within the balloon 818 during delivery through the subject's vascular system.

[0052] The outer shaft 804 may include a distal tip portion 828 mounted at its distal end. The outer shaft 804 and the intermediate shaft 806 can be axially translated relative to each other to position the distal tip portion 828 adjacent to the proximal end of the valve mounting portion 824 when the prosthetic valve 850 is mounted on the valve mounting portion 824 in a radially compressed state (as shown in Figure 25), and during the delivery of the prosthetic valve to the target implantation site. Thereafter, the distal tip portion 828 may be configured to resist the proximal axial movement of the prosthetic valve 850 relative to the balloon 818 when positioned adjacent to the proximal side of the valve mounting portion 824.

[0053] An annular space can be defined between the outer surface of the inner shaft 808 and the inner surface of the intermediate shaft 806 and can be configured to receive fluid from a fluid source through the second port 840 of the adapter 812. The annular space can be fluid-coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft 808 and the inner surface of the balloon 818. Thereafter, fluid from the fluid source can flow from the annular space into the fluid passage to inflate the balloon 818 and radially expand and deploy the prosthetic valve 850.

[0054] The inner lumen of the inner shaft may be configured to receive a guide wire through it in order to guide the distal end portion of the delivery device 800 to the target implantation site.

[0055] The handle 802 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 800. In the illustrated embodiment, for example, the handle 802 includes an adjustment member, such as the illustrated rotatable knob 860, which is operably coupled to the proximal end portion of the tension wire. The tension wire can extend distally from the handle 802 through the outer shaft 804 and has a distal end portion fixed to the outer shaft 804 at or near the distal end of the outer shaft 804. By rotating the knob 860, the tension in the tension wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 800. Further details regarding the steering mechanism or bending mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0056] The handle 802 may further comprise an adjustment mechanism 861 having an adjustment member such as a rotatable knob 862 as shown, and an associated locking mechanism having another adjustment member configured as a rotatable knob 878. The adjustment mechanism 861 is configured to adjust the axial position of the intermediate shaft 806 relative to the outer shaft 804 (for example, for fine positioning in the embedded portion). Further details of the delivery device 800 can be found in U.S. Provisional Patent Application No. 63 / 069,567 and U.S. Provisional Patent Application No. 63 / 138,890, which are incorporated herein by reference.

[0057] Figures 2 and 3 show a bare frame 50 of a prosthetic heart valve, which in one embodiment may be the frame 12 of the prosthetic valve 10 shown in Figure 1. The frame 50 has an inlet end 52, an outlet end 54, and a central longitudinal axis 56 extending (for example, axially) from the inlet end 52 to the outlet end 54. The frame 50 may be made from any of the materials previously described with reference to Figure 1. As previously described with reference to Figure 1, the frame 50 may have a plurality of commissure windows (e.g., open windows) 58 spaced apart from each other in the circumferential direction (e.g., around the periphery of the frame 50), and each of these commissure windows 58 is adapted to receive a pair of commissure tabs of a pair of valve leaflets that are positioned into the commissure.

[0058] As shown in Figure 3, the frame 50 is arranged from end to end and comprises a first lower row I of circumferentially extending diagonal support columns 60 at the inlet end of the frame, a second row II of circumferentially extending diagonal support columns 62, a third row III of circumferentially extending diagonal support columns 64, and a fourth row IV of circumferentially extending diagonal support columns 66 at the outlet end of the frame 12. The fourth row IV of the diagonal support columns 66 can be connected to the third row III of the diagonal support columns 64 by a plurality of axially extending window frame (or support column) portions 68 (defining the connecting window 58) and a plurality of axially extending support columns 70. Each axial support 70 and each frame section 68 extends from a location defined by the convergence of the lower ends of two diagonal supports 66 (also referred herein as upper support joints or upper elongated support joints) (for example, the ends furthest from the outflow end 54, inside the outflow end 54) to another location defined by the convergence of the upper ends of two diagonal supports 64 (also referred herein as lower support joints or lower elongated support joints) (for example, the ends located closer to the outflow end 54).

[0059] As used herein with reference to column ends, cells, and other frame components, “upper” and “lower” may refer to the illustrated vertical arrangement of the frame. For example, “upper” components may be located closer to the outflow end than the inflow end of the frame, while “lower” components may be located closer to the outflow end than the inflow end of the frame. Thus, in some embodiments, as described herein, the “upper end” of a column or cross-window frame portion may be referred to as the outflow-facing end with respect to the inflow and outflow ends of the frame. In other embodiments, “upper” ends, joints, or components may be referred to as “proximal” ends, joints, or components, and “lower” ends, joints, or components may be referred to as “distal” ends, joints, or components.

[0060] Each commissural window frame section 68 mounts each commissural of the valve leaflet structure (as shown, for example, in Figures 1 and 4). As can be seen in Figure 3, each frame section 68 is fixed at its upper and lower ends to adjacent rows of struts to provide a robust configuration that can increase fatigue resistance under periodic loads of the valve compared to known cantilever struts for supporting the commissural of the valve leaflet structure.

[0061] The columns and frame portions of frame 50 collectively define multiple open cells of the frame. At the inlet end 52 of frame 50, columns 60 and 62 define the lower row of cells that define the opening 72. The second and third rows of columns 62 and 64 define the middle row of cells that define the opening 74, respectively. The third and fourth rows of columns 64 and 66, together with the frame portion 68 and column 70, define the upper row of cells that define the opening 76, respectively. The opening 76 can be described as relatively large (for example, larger than the openings 72 and 74) and elongated.

[0062] In some embodiments, as used herein, the support 66 may be referred to as an oblique support 66 above the elongated cells in the upper row of cells, and the support 64 may be referred to as an oblique support 64 below the elongated cells in the upper row of cells.

[0063] The embodiment in Figure 3 shows three rows of cells with an upper row of elongated cells, but in an alternative embodiment, the frame 50 may have a different number of rows of non-elongated cells. For example, in an alternative embodiment, the frame 50 may comprise an upper row of elongated cells defining the opening 76 and a single row of cells with smaller, non-elongated openings (e.g., defining the opening 74). Yet another embodiment may comprise an upper row of elongated cells defining the opening 76 and three additional rows of cells with smaller, non-elongated openings.

[0064] In some embodiments, the frame may be smaller in diameter for smaller diameter prosthetic heart valves. For example, conventional transcatheter heart valves may have an expanded diameter in the range of 23–29 mm. As an example, smaller diameter transcatheter heart valves may have a diameter of approximately 20 mm. In some embodiments, smaller diameter valves may have a diameter of less than 22 mm. In other embodiments, smaller diameter valves may have a diameter in the range of 19–21 mm. However, these smaller diameter valves may not be used as frequently due to the various difficulties arising from their inherently smaller cell size and the arrangement of the valve leaflets within the frame. As one example, the smaller size of cells in smaller diameter valves may reduce or interfere with blood flow to the coronary artery orifice after valve-in-valve (e.g., prosthetic valve-in-prosthetic valve) procedures. As another example, smaller size cells may prevent the passage of cells in optional coronary artery reaccess devices after valve implantation.

[0065] To address these issues at least partially, the upper row of cells positioned close to the outflow end of the frame (e.g., the cell defining the opening 76 in Figure 3) may be elongated relative to the other rows of cells in the frame, as shown in Figures 2-3 and 4 (as will be further described later). However, the leaflet assemblies of the prosthetic valve, including the commissures attached in the commissure window 58 (e.g., as shown in Figure 1), may at least partially obstruct the opening of the upper row of cells, thereby reducing access to blood flow and coronary artery reaccess devices.

[0066] Therefore, it is desirable to have a commissure attachment configuration that holds the leaflets of the prosthetic valve in a position within the frame that maintains a relatively open cell region within the upper cell close to the outflow end of the frame, and that, once the prosthetic valve is implanted, is sufficient to allow blood flow to the coronary artery orifice and passage of the coronary artery reaccess device.

[0067] For example, as shown in Figure 4, a commutator 80 comprising pairs of commutator tabs 82a and 82b for each valve leaflet 84a and 84b may be positioned within the lower portion of the commutator window 58. More precisely, Figure 4 shows a detail view of a portion of the frame 50 (as the whole of which is shown in Figure 3) comprising the commutator window 58, and the pairs of commutator tabs 82a and 82b extending through the commutator window 58. As previously stated, it is desirable to maintain the commutator 80 within the lower portion of the commutator window 58 such that the commutator 80 is positioned adjacent to the lower edge of the window frame portion 68 (for example, toward the inlet or upstream end of the upper cell). As a result, the commutator 80 and the valve leaflets 84a and 84b are offset axially away from the outlet end of the valve and are maintained within the lower region 88 of the upper row of cells, thereby maintaining a relatively open space within the upper region 86 of the upper row of cells. This allows a more open cell region within the upper cell to be brought closer to the outflow end 54 of the frame 50.

[0068] Therefore, it is desirable that the frames of the prosthetic valve and / or commissure support (or mounting) elements that can be attached to the frame be configured to hold the commissures and their corresponding leaflets within the lower region (or lower portion) of the upper elongated cell. The frame and / or commissure support elements may also be configured such that the commissures can be pre-assembled outside the frame and then inserted (e.g., slid in) into the frame and / or commissure support elements (e.g., from above or below, due to at least partially open commissure windows in the frame and / or commissure support elements). This configuration and assembly method can reduce the assembly time for the prosthetic valve and improve the overall ease of manufacturing the prosthetic valve.

[0069] Figures 5, 8–11, 13–16, and 19–24 illustrate different embodiments of a prosthetic heart valve frame having elongated cells at the outflow end of the frame, where at least a portion of a plurality of elongated struts forming elongated cells is configured to receive a commissure and / or a commissure support element coupled to the commissure. The portion of the plurality of elongated struts may be configured to maintain the commissure within the lower portion of the elongated cell, positioned away from the outflow end of the frame, thereby keeping the opposite upper portion of the elongated cell open and free from obstruction by the leaflets of the prosthetic heart valve. The portion of the plurality of elongated struts may also be configured to receive a commissure support element or a pre-assembled commissure.

[0070] The frames of the prosthetic heart valves shown in Figures 5, 8-11, 13-16, and 19-24 may be similar to the frame 50 shown in Figures 2-3, and therefore the components of the frames shown in Figures 5, 8-11, 13-16, and 19-24, which are identical to the components of frame 50, are denoted by the same reference numerals. For example, the different frame embodiments shown in Figures 5, 8-11, 13-16, and 19-24 may have modified commissure window frame portions and / or axial supports that form at least partially elongated cells at the outflow end, while the rest of the frame remains similar to the rest of frame 50 (e.g., supports that form smaller lower rows of cells). Therefore, Figures 5, 8-11, 13-16, and 19-24 may only show a portion of the frame of a prosthetic heart valve, including a commissure window frame portion or support adapted to receive a commissure or commissure support element, although omitted portions of the frame may be similar to the corresponding portions of frame 50 in Figures 2-3.

[0071] Figure 5 shows a first embodiment of frame 100, which has an elongated cell at the outflow end 54 of frame 100 and a plurality of open commissar windows 102 (only one is shown in Figure 5) formed by window posts 104a and 104b extending axially in the elongated cell, each open commissar window 102 configured to receive a commissar in the lower region (or lower portion) of the open commissar window 102. Each open commissar window 102 is formed by a gap region between window posts extending axially in the adjacent elongated cell. Furthermore, each open commissar window 102 includes a lower region 118 configured to receive the commissar tab of the commissar and an upper region 116 located close to the outflow end 54 of frame 100.

[0072] More specifically, as shown in Figure 5, the open joint window 102 is formed between a first elongated cell 106a by a window post 104a extending in the first axial direction of the first elongated cell 106a and a window post 104b extending in the second axial direction of the second elongated cell 106b, the first elongated cell 106a and the second elongated cell 106b being adjacent to each other in the circumferential direction within the frame 100. The window posts 104a and 104b are spaced apart in the circumferential direction by a distance (e.g., a gap) 108. The distance 108 can be selected to accommodate the joint tabs 82a and 82b of the joint 110 (e.g., it can be the same as, slightly smaller than, or slightly larger than the width of the two joint tabs).

[0073] As shown in Figure 5, the open commissure window 102 is open at its upper end (also called the proximal end) (for example, the end closest to the outflow end 54 of the frame 100). As a result, during the assembly of the prosthetic heart valve, the commissure 110, including the integrally fixed commissure tabs 82a and 82b, can slide into the open commissure window 102 (for example, the gap 108 formed between the first axially extending window support 104a and the second axially extending window support 104b).

[0074] For example, a commissure 110 may be formed on the outside of the frame 100 by connecting commissure tabs (e.g., commissure tabs 82a and 82b) of two adjacent valve leaflets (e.g., leaflets 84a and 84b) to one another. In one embodiment, the commissure tabs of the commissure 110 may be connected to one another via one or more sutures. In one embodiment, each of the commissure tabs of the commissure 110 may be folded so as to overlap an adjacent valve leaflet and away from that leaflet (e.g., at approximately 90 degrees), and a reinforcing member may be positioned between the folded (e.g., bent) corners of the commissure tabs. The reinforcing member may be fastened to the commissure tabs via one or more fasteners (e.g., sutures). In one embodiment, the reinforcing member may be referred to as a wedge member. The reinforcing member may have a width (extending circumferentially) large enough to prevent the joint tab from being pulled back through the open joint window 102 after the joint 110 has been inserted into the open joint window 102 and the valve leaflets have been positioned within the frame 100. It should be noted that in some embodiments, the other joint described herein may be formed in a similar manner to the joint 110, as described earlier.

[0075] Each of the axially extending window supports 104a and 104b comprises a lower (or distal) window support portion 112a and 112b and an upper (or proximal) window support portion 114a and 114b. Thus, the lower region 118 of the commissar window is defined between the lower window support portions 112a and 112b, and the upper region 116 of the commissar window is defined between the upper window support portions 114a and 114b.

[0076] Furthermore, the connecting window 102 is closed at its lower end (for example, the distal end). For example, the connecting window 102 can be closed at its lower end by a lateral window support portion 113 that connects the lower ends of the lower window support portions 112a and 112b of the axially extending window supports 104a and 104b.

[0077] As shown in Figure 5, the lateral window support portion 113 is further connected to an oblique support 64 that defines a portion of the cells in a second row of cells adjacent to the upper row of elongated cells.

[0078] In this method, the lower region 118 of the connecting window is closed at its lower end, and the lower edges of the connecting tabs 82a and 82b can be positioned in contact with the lateral window support portion 113.

[0079] As shown in Figure 5, the heights 120 of each connecting tab 82a and 82b, extending between the relief edge 122 and the upper edge 124 of each connecting tab, can closely coincide with (for example, be the same as, or slightly smaller than) the height of the lower region 118 of the connecting window (which is the same as the length 128 of the lower window support sections 112a and 112b, as described later).

[0080] Because the height (e.g., length 128) of the lower region 118 of the commissure window is less than the total height of the open commissure window 102, the leaflets 84a and 84b of the commissure tabs 82a and 82b positioned in the open commissure window 102 do not obstruct at least the upper portion (e.g., upper region) 142 of the opening 76 of the elongated cells 106a and 106b. As a result, the opening 76 has an opening area that, once the prosthetic heart valve is implanted, can be large enough to ensure adequate blood flow to the coronary artery orifice and also allow a reaccess device to pass through the opening area.

[0081] In one embodiment, the length 128 of the lower window support portions 112a and 112b may be longer than the length 130 of the upper window support portions 114a and 114b. In one embodiment, the length 128 of the lower window support portions 112a and 112b is in the range of 4 to 6 mm, and the length 130 of the upper window support portions 114a and 114b is in the range of 1 to 2 mm. In one embodiment, the length 128 of the lower window support portions 112a and 112b is in the range of 4.4 to 5.5 mm, and the length 130 of the upper window support portions 114a and 114b is in the range of 1.25 to 1.75 mm. In one embodiment, the length 128 of the lower window support portions 112a and 112b is approximately 5 mm, and the length 130 of the upper window support portions 114a and 114b is approximately 1.5 mm.

[0082] In one embodiment, the upper window support portions 114a and 114b each include a recessed portion 132 that gives rise to a thinned portion of the respective upper window support portion. The length of each recessed portion 132 may be shorter than the length 130 of the respective upper window support portion 114a or 114b. As will be further described later with reference to Figures 6 and 7, the recessed portions 132 of the upper window support portions 114a and 114b may be molded to receive window fasteners (e.g., spacers).

[0083] In one embodiment, the length 128 of the lower window support sections 112a and 112b is selected to closely match the height 120 of the connecting tabs 82a and 82b.

[0084] In one embodiment, the length 130 of the upper window support portions 114a and 114b is selected to hold open cell regions within the elongated cells 106a and 106b when the commissure 80 is assembled within the respective open commissure window 102, and the open commissure window 102, once implanted, is large enough to ensure adequate blood flow to the coronary artery orifice and also allow for the passage of a reaccess device.

[0085] After a prosthetic heart valve is implanted, the valve leaflets are movable during valve operation, moving from an open position during systole to a closed position during diastole. The constant periodic movement of the valve leaflets can exert lateral forces (e.g., in the circumferential direction) on the axially extending window supports 104a and 104b, causing them to expand apart. Therefore, in some embodiments, a commissure window retainer may be inserted between the axially extending window supports of each open commissure window (e.g., window 102). The commissure window retainer may be configured to fix the axially extending window supports of the open commissure windows together to prevent lateral movement of the axially extending window supports relative to each other. In some embodiments, the commissure window retainer may be referred to as a spacer because it is adapted to maintain a relatively constant distance between the axially extending window supports of the open commissure windows in the circumferential direction (e.g., lateral direction).

[0086] Figures 6 and 7 illustrate exemplary embodiments of such a cross-linked window fastener 150. Specifically, Figure 6 shows a perspective view of the window fastener 150, and Figure 7 shows a top view of the window fastener 150 coupled into an open cross-linked window 102.

[0087] As shown in Figures 6 and 7, the window fastener 150 has an H-shape (or, in some embodiments, an I-shape). The window fastener 150 comprises an intermediate portion 152 and two opposing end portions 154 and 156, the intermediate portion 152 extending between the two end portions 154 and 156. The two end portions 154 and 156 have a width 158 that is wider than the width 160 of the intermediate portion 152.

[0088] Figure 7 shows a top view of a window fastener 150 inserted into the upper region 116 of the interlocking window 102. More specifically, in one embodiment, the intermediate portion 152 may slide downward into the upper region 116 from the open end of the interlocking window 102 (adjacent to the upper region 116). Thereafter, the intermediate portion 152 is positioned between the upper window support portions 114a and 114b, and the end portions 154 and 156 are positioned radially outward and radially inward of the frame 100 (e.g., the support columns of the frame), respectively. As used herein, radial is relative to the central longitudinal axis of the annular frame 100. In this method, the first end portion 154 extends circumferentially between the radially outward-facing sides of the upper window support portions 114a and 114b, and the second end portion 156 extends circumferentially between the radially inward-facing sides of the upper window support portions 114a and 114b.

[0089] As shown in Figure 5 and described above, in one embodiment, the upper window support portions 114a and 114b may each be provided with recesses 132 configured to receive the intermediate portion 152 of the window fastener 150.

[0090] Therefore, the window fastener 150 can be slid into the window 102 from above (e.g., the outflow end of the frame) by expanding (e.g., pushing) the upper window support portions 114a and 114b slightly apart from each other during the initial phase of insertion, until the intermediate portion 152 snaps into place in the recessed portion 132 of the upper window support portions 114a and 114b.

[0091] In one embodiment, the width 160 of the intermediate portion 152 may be approximately the same as the unloaded distance 134 (e.g., not under tension or load) between the two upper window support portions 114a and 114b of the window 102 in the region of the recessed portion 132.

[0092] As shown in Figure 6, in one embodiment, the lateral edges 162 of two end portions 154 and 156 are provided with a plurality of notches (e.g., indentations) 164 configured to receive and support a fastener (e.g., suture) extending along the lateral edge 162. For example, after the window fastener 150 is positioned in a predetermined location in the upper region 116 of the window 102, the suture 166 can form a loop around the end portions 154 and 156, securing the upper window support portions 114a and 114b which are tightly pressed against the window fastener 150.

[0093] In this method, the window fastener 150 can always maintain a relatively constant distance between the axially extending window supports 104a and 104b during the operation of the prosthetic heart valve. As a result, compression that may be applied to the commissure tabs positioned within the window 102 in other ways can be reduced or eliminated.

[0094] Referring to Figure 5, the frame 100 described earlier provides a commissure receiving portion (e.g., lower region 118) in the commissure window, configured to maintain the commissure within the lower portion 140 of the elongated cells (e.g., elongated cells 106a and 106b), the lower portion 140 being positioned away from the outflow end 54 of the frame 200. As a result, the opposite upper portion 142 of the elongated cells remains open and is not obstructed by the leaflets of the prosthetic heart valve (as shown in Figure 5).

[0095] In other embodiments, as shown in Figures 8 and 9, the frame 200 may have elongated cells at the outflow end 54 of the frame 200 and may have a plurality of open commissar windows 202 (only one is shown in Figures 8 and 9) defined between axially extending window posts parallel to the axially extending posts of the elongated cells extending from the upper axial portion of the axially extending posts. Each commissar window 202 may be open at its lower end and may be located within the lower portions of two adjacent elongated cells. For example, an axially extending window post may have a lower (or distal) clamping portion defining a bottom opening through which a commissar can slide into the commissar window 202 and which is configured to clamp together to hold the commissar inside. In this method, the commissure window 202, configured to receive the commissure (as shown in Figure 9), is positioned lower within the elongated cell (for example, away from the outflow end), thereby maintaining an open area for blood flow and device access in the upper portion of the elongated cell.

[0096] More specifically, as shown in Figures 8 and 9, the exemplary commissar window 202 is formed and defined between a first axially extending window post 204a and a second axially extending window post 204b. As shown in Figure 8, the lengths 205 of the axially extending window posts 204a and 204b are shorter than the lengths 207 of the axial supports 70 of the elongated cells 206a and 206b of the frame 200 (the axial supports 70 do not include the commissar window). The axially extending window posts 204a and 204b are formed integrally with the frame 200 and extend from an upper (e.g., proximal) axial support 208, respectively. Together, the axially extending window posts 204a and 204b and the upper axial support 208 can form an axially extending frame portion that defines the respective axial sides of adjacent elongated cells 206a and 206b.

[0097] In one embodiment, the thickness or width of the upward axial support 208, defined perpendicular to the central longitudinal axis of the frame in the circumferential direction, may be the same as the thickness or width of the axially extending window supports 204a and 204b and / or additional supports of the frame (e.g., diagonal supports 66).

[0098] In one embodiment, the thickness or width of the upper axial support 208 may be greater (e.g., thicker) than the thickness or width of the axially extending window supports 204a and 204b and / or additional supports of the frame (e.g., diagonal supports 66).

[0099] In one embodiment, the upward axial support 208 may include additional geometric features, such as one or more holes or notches along its length.

[0100] The upper axial support 208 is positioned between the upper elongated support joint 210 (for example, the joint between the two diagonal supports 66 and the upper axial support 208) and the upper edge 212 of the connecting window 202. The upper edge 212 is positioned substantially perpendicular to the upper axial support 208 and offsets the axially extending window supports 204a and 204b from each other laterally (for example, circumferentially). In other words, the upper edge 212 extends in the circumferential direction (for example, laterally) between the respective upper ends of the axially extending window supports 204a and 204b.

[0101] As shown in Figure 8, what could have been a lower, elongated support joint is replaced by the open lower end of the connecting window 202.

[0102] For example, in one embodiment, window posts 204a and 204b extending in each axial direction include downward clamping portions 214a and 214b, respectively, formed by the downward bent (e.g., oblique) portions of the window posts 204a and 204b extending in each axial direction. As shown in Figures 8 and 9, the bends of the downward clamping portions 214a and 214b are oblique to each other. Thus, as shown in Figures 8 and 9, together, the downward clamping portions 214a and 214b can form a neck region at the lower end of the open-joint window 202.

[0103] As shown in Figure 9, the commissar tabs 82a and 82b of the commissar 216 can extend through the open commissar window 202 to form a commissar assembly (e.g., a commissar assembled to a frame 200). For example, in one embodiment, the commissar tabs 82a and 82b of the valve leaflets 84a and 84b can be inserted into the commissar window 202 through an opening 218 defined between the lower clamping portions 214a and 214b.

[0104] In one embodiment, axially extending window supports 204a and 204b and their respective lower clamping portions 214a and 214b can be flexed or elastically bent laterally (for example, laterally outward so as to move away from each other) during valve leaflet insertion.

[0105] In one embodiment, once the commissar tabs are positioned within the commissar window 202 to fasten the lower ends of the axially extending window posts 204a and 204b together, and to prevent the commissar tabs 82a and 82b from sliding out of the commissar window 202 in the axial direction, the suture thread 220 may be wrapped around or looped around the lower fastening portions 214a and 214b (for example, it may be wrapped around or looped around the outward bend in each of the lower fastening portions). In an alternative embodiment, an alternative fastener or fastening means (e.g., a band, string, knot, etc.) may be used to fasten the lower fastening portions 214a and 214b together.

[0106] In one embodiment, the lower clamping portions 214a and 214b may each comprise an angled lower portion and a relatively straight horizontal upper portion. The angled portions can assist the upward sliding of the coupling tabs 82a and 82b (towards the outlet end 54) from the bottom opening into the coupling window 202. The horizontal portions can serve as a lower (e.g., bottom) base to support the coupling tabs 82a and 82b held within the coupling window 202.

[0107] In an alternative embodiment, the lower portions of the lower clamping portions 214a and 214b do not have to be angled, but instead may be relatively straight and positioned perpendicular to the horizontal upper portion.

[0108] The upper edge 212 may be configured to reduce or prevent upward axial displacement of the joint 216 in the axial direction toward the outlet end 54. In one embodiment, a wedge member (not shown) may be inserted between the joint 216 (e.g., the upper edge of the joint tab) and the upper edge 212 to further reduce or prevent undesirable axial movement of the joint 216 within the joint window 202. The wedge member may be a woven or polymer material having a thickness selected to be large enough to be firmly in contact and positioned between the upper edge 212 and the upper edges of the joint tabs 82a and 82b.

[0109] In this method, the open windows 202 of the frame 200 in Figures 8 and 9 (for example, having an open end at one end) provide a method for inserting and joining the commissures of the valve leaflet assembly into a frame having an elongated upper cell, thereby increasing the ease of manufacturing the prosthetic heart valve. Furthermore, by having open windows 202 with downward tightening portions that can be tightened together to secure the commissures within each window 202, the commissures can always be held securely within each window 202, including during the transition between the retracted and expanded states of the prosthetic heart valve frame, and during cardiac diastole (during the valve's operation in vivo).

[0110] Furthermore, in one embodiment, the axial position of the upper edge 212 (along the central longitudinal axis of the frame 200), or the axial distance between the upper edge 212 and the outflow end of the frame 200, is selected such that the valve leaflets are maintained in the lower position 240 of the elongated cell, and the upper portion 242 of the elongated cell remains unobstructed by the valve leaflets. In this manner, the commissure window 202 and, by extension, the valve leaflets are axially offset toward the inflow end (which may also be referred to as the upstream end) of the upper row of cells (e.g., cells 206a and 206b). As a result, proper blood flow and / or access via the reaccess device may be possible through the upper portion 242 of the elongated cell during valve operation.

[0111] For example, in one embodiment, the length 252 of the upper axial support 208 may be selected such that the axial distance 250 between the outflow end 54 of the frame 200 (e.g., the apex or outflow end portion of the support 66 at the outflow end 54) and the outflow edges of the valve leaflets 84a and 84b in the commissure (or the axial position of the upper edge 212 as indicated by the dotted line in Figure 9) is within a selected range. In one embodiment, the selected range of the axial distance 250 is 2–6 mm, 2–4 mm, or 2–3 mm. In one embodiment, the selected range of the axial distance 250 is 20–50%, 25–45%, or 30–40% of the total axial distance (or height) of the elongated cells 206a and 206b. In one embodiment, the length 252 of the upper axial support 208 may be in the range of 0.75–2.5 mm or 1–2 mm, or approximately 1.5 mm. As a result, the upper portion 242 of the elongated cell may be sized to provide adequate blood flow and / or access via a re-access device.

[0112] In one embodiment, the outflow edges of the valve leaflets 84a and 84b that move away from the commissure (as well as the commissure tabs 82a and 82b that move toward the center of the valve ( toward the longitudinal axis of the center of the frame)) may be higher (closer to the outflow end 54) or lower than the outflow edges of the valve leaflets 84a and 84b at the commissure tabs 82a and 82b.

[0113] In one embodiment, the outlet edges of the valve leaflets 84a and 84b (as well as the commissure tabs 82a and 82b that move toward the center of the valve ( toward the longitudinal axis of the center of the frame)) that move away from the commissure may also be offset from the outlet end 54 of the frame 200 by an axial distance of 250.

[0114] In other embodiments, as shown in Figures 10, 11, 13, and 14, a frame 300 having an elongated cell at an outlet end 54 may have a plurality of open commissar windows 302 (only one is shown in Figures 10, 11, 13, and 14) which are divided into two open window portions, the two open window portions being formed between an axial support (e.g., an axially extending support similar to the axially extending support 70) and two axial support arms positioned on either side of the axial support. In some embodiments, each of the axial support and the two axial support arms may be referred to as an axially extending window support (e.g., an axially extending window support forms two open window portions of the open commissar window 302). The two open window portions are separated from each other via the axial support and are configured to each receive different commissar tabs of the commissar.

[0115] More specifically, as shown in Figures 10 and 11, each open-connection window 302 may comprise a first open-window portion 304a and a second open-window portion 304b. The first open-window portion 304a is formed between (and defined by) the axial support column 316 and the first axial support arm 308a, and the second open-window portion 304b is formed between (and defined by) the axial support column 316 and the second axial support arm 308b.

[0116] The first axial support arm 308a and the second axial support arm 308b are formed integrally with the frame 300 and extend from an elongated support joint 310 at the bottom of the frame 300 toward the outflow end 54 of the frame 300, parallel to the axial support 316. The lower elongated support joint 310 may be the joint between two diagonal supports 64 of two adjacent elongated cells 306a and 306b. Furthermore, the axial support 316 extends between the lower elongated support joint 310 and the upper elongated support joint 311. The upper elongated support joint 311 may be the joint between two diagonal supports 66 of two adjacent elongated cells 306a and 306b.

[0117] Each of the first axial support arm 308a and the second axial support arm 308b is offset laterally (in opposite directions) from the axial support 316. In some embodiments, the lateral direction may also be referred to as the circumferential direction (since the frame 300 is annular).

[0118] In one embodiment, each of the first axial support arm 308a and the second axial support arm 308b may include a lower elongated support joint 310 and lateral portions 312a and 312b, respectively, extending between the axial portions 314a and 314b of the first axial support arm 308a and the second axial support arm 308b. The lateral portions 312a and 312b may be positioned substantially perpendicular to the axial portions 314a and 314b.

[0119] The upper ends of the first axial support arm 308a and the second axial support arm 308b, which are positioned close to the outflow end 54 of the frame 300, may be free (e.g., not connected to other supports or parts of the frame 300). As a result, the first axial support arm 308a and the second axial support arm 308b may be individually bent or displaced laterally and / or radially away from the axial support 316, and then, once the bending or displacement forces are no longer applied to them, they may return to their axial orientation (e.g., roughly parallel, radially aligned with the axial support 316). As will be further described later, the upper ends of the first axial support arm 308a and the second axial support arm 308b may include their respective upper clamping portions 318a and 318b.

[0120] As shown in Figures 11, 13, and 14, the commissure tabs 82a and 82b of adjacent valve leaflets 84a and 84b can extend through corresponding open window portions 304a and 304b of the open commissure window 302, respectively, to form a commissure 320 (the complete commissure 320 is shown in Figures 13 and 14).

[0121] In one embodiment, the unloaded (e.g., unbent or unflexed) width 362 of the open window portions 304a and 304b may be selected based on the thickness of the connecting tabs 82a and 82b (e.g., each open window portion is slightly thinner than or equal to twice the thickness of the connecting tab).

[0122] For example, the commissure tabs 82a and 82b of the valve leaflets 84a and 84b can extend through the open window portions 304a and 304b, respectively, by bending or flexing the axial support arms 308a and 308b laterally outward (away from the axial support 316) and / or radially inward (towards the central longitudinal axis of the frame 300). This facilitates the insertion of the commissure tabs into the open window portions 304a and 304b.

[0123] As shown in Figures 11, 13, and 14, the second commissar tab 82b can extend radially outward from the body of the valve leaflet 84b toward the frame 300 through the second open window portion 304b. The second commissar tab 82b can then fold into itself (for example, from its first tab portion 322b) to form a second tab portion 324b that extends radially inward through the same second open window portion 304b. The second tab portion 324b can then fold laterally outward from the axial support 316 toward the corresponding second axial support arm 308b to form a third tab portion 326b.

[0124] As shown in Figures 11 and 13, in one embodiment, the third tab portion 326b may be positioned radially inward of the frame 300 (for example, on the side facing radially inward with respect to the central longitudinal axis of the frame). Similarly, as shown in Figure 13, the first commutating tab 82a may extend radially outward from the body of the valve leaflet 84a toward the frame 300 through the first open window portion 304a. The first commutating tab 82a may then fold into itself (for example, from its first tab portion 322a) to form a second tab portion 324a extending radially inward through the same first open window portion 304a. The second tab portion 324a may fold laterally outward from the axial support 316 toward the corresponding first axial support arm 308a to form a third tab portion 326a. For ease of illustration, only the second interlocking tab 82b is shown in Figure 11, but it should be noted that the first interlocking tab 82a can be folded over as previously described and shown in Figure 13.

[0125] In an alternative embodiment, as shown in Figure 14, the third tab portions 326a and 326b can be further folded over the laterally outward-facing sides of the respective axial support arms 308a and 308b, thereby extending radially outward toward the radially outward-facing side of the frame 300.

[0126] As described above, in one embodiment, each of the first axial support arm 308a and the second axial support arm 308b includes their respective upper clamping portions 318a and 318b. For example, in one embodiment, as shown in Figures 10 and 11, the first upper clamping portion 318a bends laterally inward from the axial portion 314a of the first axial support arm 308a toward the axial support 316, extends upward toward the outflow end 54 of the frame 300, and then bends laterally outward toward the axial support 316. As a result, the first recessed portion 340a is formed in the first upper clamping portion 318a. Similarly, the second upper clamping portion 318b bends laterally inward from the axial portion 314b of the second axial support arm 308b toward the axial support 316, extends upward toward the outflow end 54 of the frame 300, and then bends laterally outward toward the axial support 316. As a result, a second recessed portion 340b is formed in the second upper clamping portion 318b. Together, the first and second recessed portions 340a and 340b of the upper clamping portions 318a and 318b form a neck region at the upper end (e.g., proximal end) of the connecting window 302 adjacent to the outflow end 54 of the frame 300.

[0127] In one embodiment, a fastener (e.g., suture, band, knot, etc.) can be wrapped around or looped around the first and second recessed portions 340a and 340b of the upper tightening portions 318a and 318b after the commissar tabs have been extended through the open window portions 304a and 304b, respectively. As a result, the upper ends of the first axial support arm 308a and the second axial support arm 308b are clamped together to the axial support 316, preventing the commissar tabs from slipping out of the open window portions 304a and 304b in the axial direction.

[0128] In one embodiment, the distance (e.g., axial length) 360 between the lower elongated support joint 310 and one of the first upper clamping portion 318a and the second upper clamping portion 318b corresponds to the height (in the axial direction) of the connecting tabs 82a and 82b.

[0129] In one embodiment, as shown in Figure 12, the valve leaflet 84b (and similarly, the valve leaflet 84a) may have an axial extension 342 formed as a ridge extending axially in a proximal (upward) direction in the transition region between the valve leaflet 84a and the commissure tab 82b. As shown in Figure 11, the axial extension 342 is aligned with the upper clamping portion 318b so as to be positioned between the upper clamping portion 318b and the axial support 316 in the lateral direction. Although only the second valve leaflet 84b is shown in Figure 12, the first valve leaflet 84a may also have an axial extension 342 positioned between the upper clamping portion 318a and the axial support 316 when inserted into the first open window portion 304a.

[0130] In this embodiment, when sutures or other fasteners are looped and tightened around the upper tightening portions 318a and 318b, the axial extensions 342 of the valve leaflets 84a and 84b are clamped and tightened between the axial support 316 and the respective upper tightening portions 318a and 318b. Thus, the axial extensions 342 can be provided to reduce the stress applied to the valve leaflets 84a and 84b during the transition between systole and diastole (during the operation of the prosthetic heart valve in vivo).

[0131] Figures 13 and 14 show top cross-sectional views of two embodiments of a joint 320 positioned within a joint window 302 formed by a frame 300. In one embodiment, as shown in Figures 13 and 14, the first tab portions 322a and 322b of the valve leaflets can be folded onto the respective reinforcing members 344a and 344b, forming second tab portions 324a and 324b, respectively, extending therefrom toward the respective open window portions 304a and 304b. In one embodiment, the reinforcing members 344a and 344b may be referred to as wedge members.

[0132] In one embodiment, as shown in Figure 13, sutures 346a and 346b can extend laterally outward from the radially inward side of the frame 300 to the radially outward side of the frame, respectively. For example, as shown in Figure 13, each of the sutures 346a and 346b can extend through the three layers of the respective commissar tabs 82a and 82b, including the respective first tab portions 322a and 322b, the second tab portions 324a and 324b, and the third tab portions 326a and 326b. In one embodiment, the sutures 346a and 346b can further extend through the respective reinforcing members 344a and 344b, which are positioned between the first tab portion and the second tab portion.

[0133] In one embodiment, fabric pieces 348a and 348b may be positioned between the second tab portions 324a and 324b, the third tab portions 326a and 326b, and the axial support arms 308a and 308b, respectively. Thus, the fabric pieces 348a and 348b can reduce friction of the cross tabs 82a and 82b against the axial support arms 308a and 308b. In one embodiment, suture threads 346a and 346b may extend through the folded or end portions of the fabric pieces 348a and 348b.

[0134] In one embodiment, fabric pieces (such as fabric pieces 348a and 348b) may be further positioned between the interlocking tabs 82a and 82b and the axial support 316 (not shown in Figure 13).

[0135] In alternative embodiments, as shown in Figure 14, the third tab portions 326a and 326b are further folded over the laterally outward-facing sides of the respective axial support arms 308a and 308b, thereby extending radially outward to the radially outward-facing side of the frame 300 (and, in some embodiments, to the outside of that radially outward-facing side). In these embodiments, a single suture 350 can extend laterally (opposite to the radial direction shown in Figure 13) on the outside of the frame 300 through the three layers of both commissure tabs 82a and 82b (for example, through a total of six leaflet tab layers).

[0136] In one embodiment, the suture thread 350 can further extend through the reinforcing members 344a and 344b.

[0137] In one embodiment, the interlocking tabs 82a and 82b may be folded onto reinforcing members 344a and 344b to form a partial pre-assembly to simplify the insertion and mounting of the frame 300 into the interlocking window as previously disclosed. For example, the interlocking 320 may be assembled outside the frame 300 by folding and securing the interlocking tabs as previously described with reference to Figures 11, 13, and / or 14, and the assembled interlocking 320 may then be inserted into the interlocking window 302 through an opening at the upper end of the interlocking window 302 formed by the free ends of the axial support arms 308a and 308b (for example, in the clamping portions 318a and 318b) (for example, by sliding it in). More specifically, the assembled commissure 320 can be slid into the commissure window from above (for example, the first folded commissure tab 82a can be slid into the first open window portion 304a through the opening between the axial support 316 and the upper clamping portion 318a, and the second folded commissure tab 82b can be slid into the second open window portion 304b through the opening between the axial support 316 and the upper clamping portion 318b). In this method, the leaflet assembly to the prosthetic heart valve can be simplified and made easier, thereby saving manufacturing time and effort.

[0138] In other embodiments, as shown in Figures 15 and 16, a frame 400 having an elongated cell at its own outlet end 54 may have a plurality of commissar windows 402 (only one is shown in Figures 15 and 16) that are integral with the rest of the frame. Each commissar window 402 may extend from the upper edge 436 of the frame 400 (e.g., at the outlet end) and may be configured to bend from an extended configuration to a bent configuration in which the commissar window 402 overlaps a support extending axially in the upper cell of the frame 400. The commissar window 402 may be a closed window formed by a support frame 404 including a wider first portion 406 connected to the outlet end 54 of the frame 400 via a bendable support portion 410 and a narrower second portion 408 configured to hold the commissar of the valve leaflet assembly inside. The bendable support portion 410 can be configured to bend through manual force and to retain its bent shape (for example, plastically deformable).

[0139] More specifically, as shown in Figures 15 and 16, the frame 400 of the prosthetic heart valve may have an upper row of elongated cells (similar to the frame 50 shown in Figures 2 and 3). Figures 15 and 16 are detail views of a portion of the frame 400 including two adjacent elongated cells in the upper row of cells, including a first elongated cell 412a and a second elongated cell 412b. The first elongated cell 412a and the second elongated cell 412b share an axial strut 70 that extends between an upper strut joint 414 (as shown in Figure 15), which is the joint between the lower ends of two diagonal struts 66 (e.g., the ends located furthest from the outflow end 54, inside the outflow end 54), and a lower strut joint 428 (as shown in Figure 16), which is the joint between the upper ends of two diagonal struts 64 (e.g., the ends located closer to the outflow end 54).

[0140] As described above, the frame 400 may have multiple integrally formed commissar windows (only one commissar window 402 is shown in Figures 15 and 16) spaced apart around the periphery of the frame 400. Each commissar window 402 may extend from the upper edge of the frame (e.g., the proximal edge) 436 (e.g., the edge located closest to the outflow end 54 and equipped with an oblique support 66) and bend to overlap with the axial support of the upper cell (e.g., an axial support 70).

[0141] As shown in Figure 15, the interlocking window 402 is formed as a closed window (for example, without any openings around its perimeter) surrounded by the support frame 404. The support frame 404 is continuous with one another and may comprise a plurality of connected support sections that form a wider first section 406 and a narrower second section 408 of the support frame 404. The second section 408 is directly connected to the upper edge 436 of the frame 400 at one of the upper elongated support joints 414 via a bendable support section 410.

[0142] In one embodiment, the frame 404 of the interlocking window 402 is formed by a known manufacturing method such as laser cutting.

[0143] The bendable support section (also referred to as the bendable support) 410 may include an axial support configured to bend (for example, positioned parallel to the central longitudinal axis of the frame 400). In some embodiments, the bendable support section 410 is flexible and plastically deformable to transform the connecting window 402 from an upwardly extended configuration (also referred to as a fully extended configuration, as shown in Figure 15) to a fully bent or inverted configuration (as shown in Figure 16). Thus, in some embodiments, the bendable support section 410 may include a plastically deformable material, such as a plastically deformable metal or plastic.

[0144] In this method, the bendable support portion 410 may be configured to allow the crossover window 402 to be bent around the upper elongated support joint 414 via the bendable support portion 410 through manual force, and to maintain the bent orientation when no more manual force (exceeding a set threshold) is applied to the crossover window 402. As a result, spontaneous or undesirable displacement of the crossover window 402 from the selected orientation can be avoided.

[0145] As shown in Figure 15, the first portion 406 has a first length 416 (in the axial direction) and a first width 418 (in the transverse or circumferential direction), and the second portion 408 has a second length 420 and a second width 422. The second length 420 is longer than the first length 416, and the first width 418 is wider than the second width 422. The lengths and widths of the first and second portions may be selected to accommodate the commissure tab of the commissure and to position the leaflets within the lower portion of the upper cell, as will be further described later.

[0146] Figure 17 shows a method 500 for assembling a commissure within a commissure window 402 and securing the commissure window containing the commissure to a frame 400. An exemplary commissure 424 assembled within a commissure window 402 and secured to a frame 400 is shown in Figure 16. The commissure 424 may comprise commissure tabs 82a and 82b of adjacent valve leaflets 84a and 84b, as shown in Figure 16.

[0147] Method 500, in reference numeral 502, begins by at least partially bending the commutation window 402 to a selected orientation between a fully extended initial orientation (e.g., as shown in Figure 15) and a fully bent (e.g., inverted) orientation (e.g., as shown in Figure 16). The fully extended orientation may be one in which the bendable support portion 410 is not bent and substantially extends outward in the axial direction from the upper elongated support joint 414. In one embodiment, the method in reference numeral 502 may include bending the commutation window 402 by 90° to 135° relative to the fully extended orientation. In another embodiment, the method in reference numeral 502 may include bending the commutation window 402 by 80° to 160° relative to the fully extended orientation. In yet another embodiment, the method in reference numeral 502 may include bending the commutation window 402 by 75° to 140° relative to the fully extended orientation.

[0148] Method 500 continues to reference numeral 504 for inserting a pre-assembled commissure into the commissure window 502. In some embodiments, each commissure may be pre-assembled outside the frame 400 of the prosthetic heart valve. For example, in some embodiments, a pre-assembled commissure may comprise two commissure tabs of two adjacent leaflets (e.g., leaflets positioned adjacent to each other within the frame 400) that are folded into a desired configuration and secured together via one or more reinforcing (e.g., wedge) members and / or fasteners (e.g., sutures). The desired folded configuration of the commissure tabs may comprise one or more overlapping layers of commissure tabs that can consequently fit more securely into the commissure window and reduce the possibility of the commissure being pulled out through the commissure window after placement in the frame (e.g., during valve action in vivo).

[0149] In one embodiment, insertion of the joint 424 into the joint window 402 can be facilitated by a wider first portion 406 of the joint window 402. For example, the joint 424 may be first inserted into the first portion 406 and then slid and extended into a narrower, more elongated second portion 408. In this manner, the wider first width 418 can be selected to allow for easy insertion of the joint 424 into the joint tab, and the narrower second width 422 can be selected to firmly hold the joint tab of the joint 424 inside.

[0150] For example, the second length 420 and second width 422 of the second part 408 may be selected to accommodate the cross joint 424 (for example, having a length and width configured to firmly hold the cross joint tab of the cross joint inside). Also, in one example, the first length 416 and first width 418 of the first part 406 may be selected to allow the insertion of the cross joint into the cross joint window 402 (for example, with less effort) during the assembly process.

[0151] Furthermore, in one embodiment, the length 434 of the bendable support portion 410 and the dimensions of the first and second portions of the support frame 404 of the commissure window 402 (e.g., the length and width described earlier) can be selected to position the second portion 408 of the commissure window 402 closer to the lower portion of the elongated cell (e.g., elongated cells 412a and 412b), thereby keeping the first portion 408 (including the commissure 424) spaced apart from the upper edge 436 of the elongated cell. As a result, the valve leaflets can be positioned within the lower portion of the elongated cell in a configuration with a smaller profile, while remaining unobstructed from the upper portion (or region) of the upper elongated cell. As discussed herein, this configuration can enable re-access and / or proper blood flow through the upper elongated cell following a valve-in-valve procedure.

[0152] In one embodiment, the value obtained by subtracting twice the thickness of the frame 404 from the first length 416 can be approximately 2 mm (e.g., the internal length of the first portion 406, or the length of the open space), the first width 418 can be approximately 3 mm, and the second width 422 can be approximately 0.8 mm. In another embodiment, the value obtained by subtracting twice the thickness of the frame 404 from the first length 416 can be in the range of approximately 1.5 to 2.5 mm, the first width 418 can be in the range of 2.5 to 3.5 mm, and the second width 422 can be in the range of 0.6 to 1.0 mm. It should be noted that the above embodiments of the dimensions of the support frame are illustrative and not intended to be limiting.

[0153] Returning to Figure 17, method 500 can proceed from reference numerals 504 to 506 to further bend the interlocking window 402 (in which the interlocking is located) into a fully bent configuration in which the interlocking window 402 is positioned substantially parallel to the axial support 70 (as shown in Figure 16). In this fully bent configuration, the interlocking window 402 may be positioned radially inward of the axial support 70 with respect to the central longitudinal axis of the frame 400. In some embodiments, the interlocking window 402 may be aligned with the central longitudinal axis of the interlocking window 402 in the lateral (or circumferential) direction. For example, in the fully bent configuration as shown in Figure 16, the interlocking window 402 may be positioned radially in front of the axial support 70.

[0154] Next, Method 500 proceeds to reference numeral 508 to fix (e.g., attach) the lateral edge 426 (for example, which may be referred to as the lower edge in a fully curved configuration) of the second portion 408 of the connecting window 402 to the frame 400. The lateral edge 426 is positioned opposite the lateral edge 430 of the first portion 406. In one embodiment, fixing the lateral edge 426 to the frame 400 involves fixing the lateral edge 426 to the lower strut joint 428 and / or strut portions (e.g., diagonal struts 64) extending from the lower strut joint 428 (e.g., via one or more fasteners, such as one or more sutures 432 as shown in Figure 16).

[0155] In one embodiment, method 500 may further include inserting a wedge or spacer into the first portion 406 after the joint 424 has been positioned in the second portion 408 as previously described in reference numeral 510. In one embodiment, the wedge or spacer may be fastened (e.g., sutured) above the joint tabs 82a and 82b. Thereafter, the joint tabs 82a and 82b can be securely wedged into the second portion 408 of the frame 404 of the joint window 402, thereby preventing radial displacement of the joint 424 within the joint window 402. In one embodiment, the wedge or spacer may include a polymer or woven material.

[0156] In this method, the commissure window and frame configuration discussed above with reference to Figures 15-17 can be manufactured and assembled more easily because the valve leaflet commissure can be pre-assembled outside the frame and more easily inserted through the wider first portion of the commissure window. Furthermore, the ability to orient the commissure window to any desired angle (relative to the frame) during the assembly process can further simplify the process of attaching the commissure to the frame.

[0157] Furthermore, by providing a jointed window formed integrally with the frame, the number of separately attachable components is reduced, thereby further lowering manufacturing costs and making the assembly process less time-consuming. In addition, the integrally formed jointed window can prevent undesirable relative movement between other attachable components, which can reduce or eliminate fretting corrosion between contacting components.

[0158] The embodiments of the frame disclosed above with reference to Figures 5 to 17 provide a frame for a prosthetic heart valve having an upper row of cells (e.g., located at the outflow end of the frame) that is axially elongated relative to the remaining rows of cells of the frame (e.g., lower cells located closer to the inflow end of the frame). As discussed above, these integral commissure windows are configured to hold the valve leaflet assembly in a lower position within the upper row of cells, thereby creating open space for increased blood flow and / or passage of a reaccess device through the upper row of cells.

[0159] In an alternative embodiment, the frame of a prosthetic heart valve, such as the frame 50 shown in Figures 2 and 3, may be configured to receive a commissure support element. The commissure support element may be separate from the frame (e.g., not integrated) and may be configured to be coupled to (e.g., attached to) a portion of the frame. Furthermore, the commissure support element may be configured to hold the commissure within an open window of the commissure support element.

[0160] In one embodiment, a commissure support element 602 is provided that can be attached to a frame 600 of a prosthetic heart valve, as shown in Figures 18 to 21. Specifically, the commissure support element 602 can be configured to attach to a cell in the upper row of elongated cells of the frame 600 (for example, a cell forming an elongated opening 76 in the frame 50 in Figures 2 and 3). The commissure support element 602 may comprise a coupling portion adapted to bond to the upper edge of the upper row of cells at the boundary between two adjacent cells in the upper row of cells, and an open leaflet receiving window adapted to receive a commissure. In one embodiment, a pre-assembled commissure assembled outside the frame 600 can be slid into the open leaflet receiving window and secured to the commissure support element 602, and the commissure support element 602 can then be attached to the frame, thereby simplifying the process of assembling and manufacturing the prosthetic heart valve. Furthermore, the commissure support element 602 can be further configured to position the commissure within the lower region of the upper row of cells, thereby leaving an upper region that is not obstructed by the leaflets of the upper row of cells.

[0161] The joint support element 602 is shown by itself in Figure 18 and is attached to the frame 600 in Figures 19 to 21. The joint support element 602 may be configured as a single wire-shaped body 604 including a coupling portion 606 and a valve leaflet receiving window 608 defined by axially extending first and second members (e.g., first and second axial members) 610 and 612 and a connecting member 614 (substantially extending between the first axial member 610 and the second axial member 612). In Figure 20, the joint support element 602 is shown with a joint 620 located in the valve leaflet receiving window 608, and in Figures 19 and 21, it is shown without the joint (for a better illustration of how the joint support element 602 is attached to the frame 600).

[0162] In one embodiment, the wire-shaped body 604 may be formed by a known manufacturing process, such as pipe cutting, 3D printing, or other suitable process.

[0163] In one embodiment, as shown in Figure 18, each of the first axial member 610 and the second axial member 612 comprises an upward axial portion 626 and a downward axial portion 628. For example, each downward axial portion 628 extends between a connecting member 614 and a bend 630 between the downward axial portion 628 and the upward axial portion 626. Each upward axial portion 626 extends between the bend 630 and a corresponding curved portion or curved member 622 or 624 (as further described later). As shown in Figure 18, the width 632 between each downward axial portion 628 of the first axial member 610 and the second axial member 612 is wider than the width 634 between each upward axial portion 626 of the first axial member 610 and the second axial member 612. The width 632 is the width of the valve leaflet receiving window 608 (also called the commutating window).

[0164] The coupling portion 606 may comprise a pair of coupling members 616 and 618 radially offset from the first axial member 610 and the second axial member 612. Coupling member 616 can be coupled to the first axial member 610 by a curved portion or curved member 622, and coupling member 618 can be coupled to the second axial member 612 by a curved portion or curved member 624. In certain embodiments, the curved members 622 and 624 may be curved at 180° such that the first axial member 610 and the second axial member 612 extend parallel or substantially parallel to the coupling members 616 and 618 toward, for example, the inlet of a prosthetic heart valve in which the frame 600 is part, but other configurations are possible.

[0165] In one embodiment, as shown in Figure 18, the angular or circumferential spacing between the connecting members 616 and 618 may be greater than the angular spacing between the upper axial portions 626 of the first and second axial members 610 and 612. Thus, the curved members 622 and 624 may be angled toward each other.

[0166] As described above, members 610, 612, and 614 can at least partially define a valve leaflet receiving window 608 that can be opened at the top (for example, at the ends of the commissure support element 602, including the curved members 622 and 624). As a result, in one embodiment, the assembled commissure can slide into the valve leaflet receiving window 608 through the space between the curved members 622 and 624 and through the space between the upward axial portions 626 (for example, from above), as will be described further later.

[0167] Figures 19–21 show portions of an exemplary frame 600, which may be similar to frame 50 in Figures 2 and 3, as previously described. For example, frame 600 may include multiple rows of cells, and the first and second rows of cells located near the distal end 640 of frame 600 (which may be the inlet end of the frame) include cell 642 defined by four struts extending between four joints or apex (shown as roughly diamond-shaped cells in Figures 19–21, but the cells may take other shapes if, for example, the struts are curved). The upper row of cells located closer to the proximal end 644 of frame 600 (which may be the outlet end 54 of frame 600) comprises elongated cells 646 defined by six struts, two of which are elongated struts extending axially on both sides of cell 646, and are referred to herein as axial struts 70.

[0168] Frame 600, and other frames disclosed herein, may include any other number of cell rows with cells 642, insofar as the upper (i.e., proximal) row includes elongated cells 646. As previously described, in some embodiments this configuration may be used for valves of smaller diameter, in which the elongated cells 646 provide a larger cell opening through which coronary artery reaccess procedures can be performed.

[0169] As shown in Figures 19 and 20, the cross-support element 602 can be coupled to an elongated cell 646. More specifically, the cross-support element 602 can be coupled to the oblique struts 66 that form the upper edge 648 of two adjacent elongated cells 646. For example, as shown in Figures 19 and 20, the coupling members 616 and 618 hook around the oblique struts 66 of two adjacent elongated cells (for example, coupling member 616 overlaps the oblique strut 66 of the first elongated cell of two adjacent elongated cells 646, and coupling member 618 overlaps the oblique strut 66 of the second elongated cell of two adjacent elongated cells 646).

[0170] In this coupling configuration, the coupling members 616 and 618 of the commissure support element 602 are positioned radially outward of the frame 600 (with respect to the central longitudinal axis of the annular frame 600), while the first axial member 610 and the second axial member 612 are positioned radially inward of the frame 600. In this coupling configuration, the valve leaflet receiving window 608 is positioned substantially radially inward of the elongated axial support column 70 (forming a portion of each or a common axial side of two adjacent elongated cells to which the commissure support element 602 is coupled). As a result, the axial support column 70 divides the valve leaflet receiving window 608 of the commissar support element 602 into two open window portions: a first window portion 650a defined between the axial support column 70 and the downward axial portion 628 of the first axial member 610, and a second window portion 650b defined between the axial support column 70 and the downward axial portion 628 of the second axial member 612.

[0171] As shown in Figure 20, the joint tabs 82a and 82b of the joint 620 can be inserted into the leaflet receiving window 608 such that the first joint tab 82a extends through the first window portion 650a and the second joint tab 82b extends through the second window portion 650b (for example, they can be slid downward into the leaflet receiving window 608 from above before the joint support element 602 is attached to the frame 600). For example, in one embodiment, the first joint tab 82a and the second joint tab 82b can be joined together to form the joint 620. The formed joint 620 can then be slid into the leaflet receiving window 608 of the joint support element 602 while the joint support element 602 is removed from the frame 600 (as shown in Figure 18). The joint support element 602, including the joint 620, can then be attached to the frame as shown in Figure 20.

[0172] In one embodiment, after the cross support element 602 is attached to the frame 600, a first fastener (e.g., suture) 652 may be used to attach the connecting member 614 to the frame 600. In another embodiment, the connecting member 614 may be coupled to the lower support joint 654 of the frame 600.

[0173] In one embodiment, a second fastener (e.g., one or more sutures) 656 may be used to secure the upper axial portions 626 of the first and second axial members 610 and 612 and / or the connecting members 616 and 618 to the frame 600 (e.g., oblique supports 66 forming the upper edges 648 of two adjacent elongated cells 646).

[0174] The axial length 658 of the lower axial portion 628 may be configured such that the first window portions 650a and the second window portions 650b, which are configured to receive the commissure tabs 82a and 82b of the commissure 620, are shorter than the length 660 of the axial support 70. As a result, the commissure 620 is positioned in the lower region 670 of the elongated cell 646 such that the valve leaflets 84a and 84b do not obstruct the upper region 672 of the elongated cell opening. The unobstructed upper region of the elongated cell 646 may be large enough to allow sufficient blood flow to the coronary artery orifice after valve implantation, as well as large enough to allow a coronary artery reaccess device to pass through the upper region.

[0175] In alternative embodiments, the commissar support element can be configured as a relatively planar member, with curved members 622 and 624 offsetting the connecting members 616 and 618 only laterally (and not radially outward) from the first axial member 610 and the second axial member 612. In such embodiments, all parts of the commissar support element, including the connecting members 616 and 618, are positioned along the inner surface of the frame 600 (for example, in the same plane) when the commissar support element is coupled to the frame. In these embodiments, the attachment of the commissar tabs and the stitching of the members around the frame can be performed in a manner similar to that described earlier. Such configurations of the commissar support element can reduce the contour when the valve is retracted without having connecting members 616 and 618 extending outward from the frame 600.

[0176] During the operation of the prosthetic heart valve, having the frame 600 in the body allows the valve leaflets to move from an open state during systole to a closed state during diastole. The constant periodic movement of the leaflets can exert forces on the axial strut 70 that may lead to material fatigue and degradation over time. Therefore, in one embodiment, as shown in Figure 21, an axial strut 662 configured to be coupled with a commissure support element 602 may have a thickness 664 greater than the thickness 668 of an axial strut 6666 that is not configured to be coupled with a commissure support element 602. This allows the thicker axial strut 666 to be better adapted to withstand the increased stress.

[0177] In other embodiments, as shown in Figures 22 to 24, a frame 700 having elongated cells at its own outflow end 54 (for example, similar to the frame 50 in Figures 2 and 3) may have axial supports 702 including support windows 704. For example, adjacent elongated cells share an axial support extending between an upper elongated support joint 706, which is the joint between the lower ends of two diagonal supports 66 (for example, the ends located furthest from the outflow end 54 inside the outflow end 54), and a lower elongated support joint 708, which is the joint between the upper ends of two diagonal supports 64 (for example, the ends located closer to the outflow end 54). The axial supports of the upper row of cells can be either straight axial supports 70 (as shown in Figures 2 and 3) or windowed axial supports 702 (as shown in the detailed drawings in Figures 22 to 24) that include a support window 704 configured to receive a commissure support element 710, the commissure support element 710 configured to receive a commissure. For example, the frame 700 may have three windowed axial supports 702 (spaced apart from each other around the periphery of the annular frame 700), while the remaining axial supports forming the upper row of cells are straight axial supports 70 (e.g., without a support window 704). The number of axial supports 702 with support windows 704 may correspond to the number of commissures in the leaflet assembly of the prosthetic heart valve. In alternative embodiments, the frame 700 may have more or fewer than three axial supports 702.

[0178] As will be further described later, the commissure support element 710 may comprise a coupling portion adapted to connect to a column window 704 and an open leaflet receiving window 734 adapted to receive the commissure into it. In one embodiment, a pre-assembled commissure assembled outside the frame 700 can be slid into the open leaflet receiving window 734 and secured to the commissure support element 710, which can then be attached to the column window 704 of the axial column 702, thereby simplifying the process of assembling and manufacturing the prosthetic heart valve. The column window 704 can also be positioned at a selected position along the length of the axial column 702 to place the commissure within the lower region of the elongated cells in the upper row of cells, thereby leaving the upper region of the elongated cells in the upper row of cells unobstructed by the leaflets.

[0179] Figures 22–24 show detailed parts of an exemplary annular frame 700, which includes one axial support column 702, positioned between a first elongated cell 712a and a second elongated cell 712b in the upper row of cells, and forming the axial sides of each of the first and second elongated cells 712a and 712b. The first and second elongated cells 712a and 712b are positioned adjacent to each other in the upper row of cells of the frame 700. As previously discussed, the remainder of the frame 700 may be similar to the frame 50 in Figures 2 and 3, and / or other frames described herein. Figure 22 shows the bare frame 700, Figure 23 shows a cross support element 710 attached to the support window 704 of the frame 700, and Figure 24 shows the cross support element 710 attached to the support window 704 with the cross jointed inside.

[0180] As shown in Figure 22, the axial support column 702 comprises an upper (e.g., proximal) support portion 714, a lower (e.g., distal) support portion 716, and a support window 704 positioned between the upper support portion 714 and the lower support portion 716. For example, the upper support portion 714 extends axially between an upper elongated support joint 706 and a first lateral support portion 718 of the support window 704, and the lower support portion 716 extends axially between a second lateral support portion 720 of the support window 704 and a lower elongated support joint 708.

[0181] The upper support portion 714 has a first length 728, and the lower support portion 716 has a second length 730. In one embodiment, as shown in Figure 22, the first length 728 is shorter than the second length 730. As will be further described later, the first length 728 and the second length 730 can be selected so that the support window 704 is spaced apart from the upper elongated support joint 706, thereby positioning the valve leaflet commissures within the lower regions of the first and second elongated cells 712a and 712b.

[0182] Together, the first lateral support portion 718, the second lateral support portion 720, the first axial support portion 722, and the second axial support portion 724 of the support window 704 form a closed support window 704 and define the central opening 726 of the support window 704. In this method, the support window 704 may be a closed rectangular frame with a central opening 726, as shown in Figure 22. However, in alternative embodiments, the support window 704 may have different shapes, such as oval, circular, or square.

[0183] The support window 704 is configured to receive a rib support element 710 into its central opening 726 (as shown in Figures 23 and 24). As shown in Figure 23, the rib support element 710 may be configured as a single wire-shaped body 732 including a coupling portion configured to couple with the support window 704 and a valve leaflet receiving window 734 defined by axially extending first and second members (e.g., first and second axial members) 736 and 738 and a connecting member 740 (substantially extending between the first axial member 736 and the second axial member 738). In Figure 24, the rib support element 710 is shown with a rib 741 located within the valve leaflet receiving window 734, and in Figure 23, it is shown without the rib (for a better illustration of how the rib support element 710 is attached to the frame 700).

[0184] In one embodiment, the wire-shaped body 732 may be formed by a known manufacturing process, such as pipe cutting, 3D printing, or other suitable process.

[0185] In one embodiment, as shown in Figures 23 and 24, the coupling portion may comprise a pair of coupling members 742 and 744 radially offset from the first axial member 736 and the second axial member 738. Coupling member 742 can be coupled to the first axial member 736 by a curved portion or curved member 746, and coupling member 744 can be coupled to the second axial member 738 by a curved portion or curved member 748. In a particular embodiment, coupling members 742 and 744 may be curved at 180° such that the first axial member 736 and the second axial member 738 extend parallel or substantially parallel to coupling members 742 and 744 in the direction of the central longitudinal axis of the frame 700, for example, but other configurations are possible.

[0186] In one embodiment, as shown in Figures 23 and 24, the angular or circumferential distance between the connecting members 742 and 744 may be smaller than the angular distance between the first axial member 736 and the second axial member 738.

[0187] As previously described, members 736, 738, and 740 can at least partially define a valve leaflet receiving window 734 that can be opened at the top (for example, the end located closest to the outlet end 54 of the frame 700 when the joint support element 710 is coupled to the support window 704). As a result, in one embodiment, an assembled joint (e.g., joint 741) can be slid into the valve leaflet receiving window 608 from above, as will be further described later.

[0188] As shown in Figures 23 and 24, the cross-support element 710 can be coupled to the column window 704 by sliding coupling members 742 and 744 through the central opening 726, such that the curved members 746 and 748 are positioned across the second lateral column portion 720 (which may form the lower edge) of the column window 704.

[0189] As shown in Figures 23 and 24, when the cross-linked support element 710 is coupled to the support window 704, the first axial member 736 and the second axial member 738 are positioned radially inward of the frame 700 with respect to the central longitudinal axis of the annular frame 700, while the coupling members 742 and 744 are positioned radially outward of the frame 700.

[0190] The central opening 726 of the support window 704 may be sized (e.g., dimensions) to accommodate the curved members 746 and 748 of the cross-support element 710. For example, in one embodiment, the width 750 (arranged laterally or circumferentially) of the central opening 726 may be slightly smaller than the free-state distance (in the laterally) between the outer edges of the curved members 746 and 748. As a result, the user can move the curved members 746 and 748 slightly toward each other (e.g., via clamping) during insertion into the support window 704. In such an embodiment, once positioned in the central opening 726, the curved members 746 and 748 may be biased laterally toward the inner edges of the first and second axial positions 722 and 724 of the support window 704. As a result, the cross-support element 710 may be held more securely within the support window 704.

[0191] As shown in Figure 23, the valve leaflet receiving window 734 of the coupling support element 710 may be positioned immediately radially inward of the lower support portion 716 (for example, covering it) such that the lower support portion 716 divides the valve leaflet receiving window 734 into two window portions: a first window portion 734a defined between the lower support portion 716 and the first axial member 736, and a second window portion 734b defined between the lower support portion 716 and the second axial member 738.

[0192] As shown in Figure 24, the commissure tabs 82a and 82b may extend through their respective corresponding first window portions 734a and second window portions 734b. In one embodiment, the commissure 741, including the commissure tabs 82a and 82b, is at least partially pre-assembled and inserted into the valve leaflet receiving window 734 of the commissure support element 710 before the commissure support element 710 is coupled to the frame 700.

[0193] In one embodiment, a first fastener (e.g., a suture) 752 can be used to secure the connecting member 740 of the cross support element 710 to the frame 700. For example, as shown in Figure 23, the first fastener 752 can secure the connecting member 740 to the lower elongated support joint 708.

[0194] In one embodiment, additional sutures (not shown) may be used to secure the first axial member 736 and the second axial member 738 together, and / or to secure the cross support element 710 to the support window 704.

[0195] In one embodiment, a wedge or spacer member (not shown) may be inserted between the curved members 746 and 748 and the first lateral support portion 718 of the support window 704 to reduce or prevent undesirable axial movement of the cross support element within the central opening 726.

[0196] In one embodiment, the first axial member 736 and the second axial member 738 of the commissure support element 710 are provided with a tapered cross-sectional shape in the axial direction, such that their thickness increases towards the upper end (for example, the end connected to the curved members 746 and 748). Such a configuration can help reduce the stress applied to the valve leaflets during cardiac diastole.

[0197] In this method, the frame 700 provides axial support to the interlocking support element 710, since both the upper and lower portions of the interlocking support element 710 are fixed to the frame 700. Furthermore, the disclosed support window 704 can further restrict undesirable axial displacement of the interlocking support element 710.

[0198] Examples of additional disclosed technologies In light of the previously described practices of the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that any individual feature of an example, or a combination of one or more features of that example, or a combination of one or more features of any further example, also constitutes further examples within the scope of the disclosure of this application.

[0199] Example 1. A method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly, the method comprising: inserting a commissure, pre-assembled outside the annular frame, into a commissure window of the frame through an opening in the upper or lower portion of the commissure window, the commissure comprising a pair of commissure tabs fixed integrally to adjacent leaflets of the leaflet assembly, each commissure window being formed by axially extending struts of two adjacent cells in an upper row of cells of the frame, the upper row of cells being located at the outflow end of the frame and having an elongated length in the axial direction relative to the central longitudinal axis of the frame with respect to the cells in the remaining rows of cells of the frame; and securing the commissure in a commissure receiving portion of the commissure window via one or more fasteners such that the commissure is located in the lower portion of the upper row of cells and an open area unobstructed by the leaflets is formed in the upper portion of the upper row of cells, the upper portion being located closer to the outflow end than the lower portion.

[0200] Example 2. A method of any example herein, particularly the method of Example 1, wherein a commissar window is formed by two axially extending window posts spaced apart from each other in the circumferential direction, the first of the two axially extending window posts forming the axial side of a first cell in an upper row of cells, the first of the two axially extending window posts forming the axial side of an adjacent second cell in an upper row of cells, the commissar window comprising a closed lower region configured to receive commissar tabs of a commissar and an open upper region located at the outflow end of the frame, and the step of securing a commissar in the commissar receiving portion of the commissar window comprises the steps of positioning the commissar in the lower region of the commissar window and securing a window fastener to the upper region of the commissar window via one or more fasteners.

[0201] Example 3. A method of any example herein, particularly the method of Example 2, in which the steps of securing a window fastener to an upper region include first positioning the middle portion of the window fastener within the upper region of a cross window such that a relatively constant distance is maintained between two axially extending window posts, and second forming a loop with one or more sutures around the end portions of the window fastener, the end portions being positioned radially inward and radially outward of the frame, and the middle portion extending between the end portions to secure the window fastener to the frame.

[0202] Example 4. A method of any example herein, particularly the method of Example 1, wherein the commissar window is formed by two axially extending window posts spaced apart from each other in the circumferential direction, and the lower ends of the two axially extending window posts are connected, at their lower ends, along their length, to the corresponding lower oblique posts of one of two adjacent cells, and the two axially extending window posts are connected at their upper ends to an upper axial post via the upper edge of the commissar window, and the upper axial post is connected at its upper end to an upper elongated post joint that forms a joint between the upper oblique posts of two adjacent cells, and sliding the commissar through an opening is a method of any example herein, particularly the method of Example 1.

[0203] Example 5. A method according to any example herein, particularly the method of Example 4, in which the step of securing a cross joint in a cross joint receiving portion of a cross joint window is to wrap and tighten one or more fasteners around a lower tightening portion of a window post extending in two axial directions, the lower tightening portion forming an open neck region at the lower end of the window post extending in two axial directions so that the lower end of the window post extending in two axial directions is tightened integrally.

[0204] Example 6. The joint window is divided into a first open window section and a second open window section, each of which is configured to receive different joint tabs of the joint, the first open window section is formed between a central axially extending support extending between an upper and lower diagonal support between two adjacent cells and a first axial support arm which is connected to the axially extending support at the lower end of the first axial support arm and is laterally offset from the axially extending support in the circumferential direction relative to the circumference of the annular frame, the second open window section is formed between an axially extending support and the lower end of the second axial support A method according to any example herein, particularly the method of Example 1, wherein the step of inserting the crossbar into the crossbar window is formed between a second axial support arm connected to an axially extending support and laterally offset from the axially extending support, and the step of inserting the crossbar into the crossbar window through an opening is formed between the first axial support arm and the axially extending support and the first crossbar tab of the crossbar into the first open window portion, and the step of inserting the second crossbar tab of the crossbar into the second open window portion through an opening formed between the second axial support arm and the axially extending support.

[0205] Example 7. A method according to any example herein, particularly the method of Example 6, wherein the step of securing a cross joint in the cross joint receiving portion of a cross joint window includes tightening fasteners around the free upper ends of the first and second axial support arms in order to fasten the first and second axial support arms together to an axially extending support.

[0206] Example 8. The annular frame is radially expandable to a diameter in the range of 19–21 mm, according to any example method herein, in particular any one of Examples 1–7.

[0207] Example 9. Multiple interconnected pillars defining multiple columns of cells, the multiple columns being positioned between the outflow end and the inflow end of a frame, comprising an upper column of cells positioned at the outflow end and a lower column of cells positioned at the inflow end, wherein the cells of the upper column of cells are elongated in the axial direction with respect to the central longitudinal axis of the frame, with respect to the cells of the remaining columns of cells in the multiple columns of cells, including the lower column of cells, and multiple commasting windows formed between window pillars extending in the axial direction of the frame, each commasting window extending in the axial direction of two adjacent elongated cells in the upper column of an open cell. A prosthetic heart valve comprising: an annular frame having multiple commissure windows, each commissure window having a commissure receiving portion spaced apart from the upper ends of two adjacent elongated cells, the upper ends of which are located at the outflow end and open end of the frame; and a leaflet assembly having multiple leaflets, each leaflet having a commissure tab facing the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, each commissure being located within the commissure receiving portion of its respective commissure window, and the open end of the commissure window being configured to receive the commissure through the open end.

[0208] Example 10. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 9, wherein the open end of each commissure window is formed by the upper or lower end of axially extending window posts that are spaced apart from each other in the circumferential direction and not directly connected to each other, the circumferential direction being relative to the circumferential portion of the frame and arranged in contact with the axial direction.

[0209] Example 11. A prosthetic heart valve according to any example herein, particularly any one of Examples 9 to 10, wherein each commissure window is formed between a first axially extending window post of a first elongated cell of two adjacent elongated cells and a second axially extending window post of a second elongated cell of two adjacent elongated cells, the first axially extending window post and the second axially extending window post are spaced apart from each other along the length of their respective windows posts at their upper ends and connected to each other at their lower ends by a lateral window post portion, each of the first axially extending window post and the second axially extending window post comprises a lower window post portion and an upper window post portion, and the commissure receiving portion of the commissure is formed in the space between the lower window post portion of the first axially extending window post and the lower window post portion of the second axially extending window post.

[0210] Example 12. Each interlocking window is formed between a window support extending in a first axial direction and a window support extending in a second axial direction, the first and second axial window supports being spaced apart from each other circumferentially along the length of their respective lower ends, and the lower ends of the first and second axial window supports being connected to the corresponding lower oblique support of one of two adjacent elongated cells. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 9 or Example 10, wherein a first axially extending window post and a second axially extending window post are connected to each other and connected at their upper ends to an upper axial post via the upper edge of a circumferentially extending commissure window, the upper axial post being connected at its upper end to an upper elongated post joint that forms a joint between the upper oblique posts of two adjacent elongated cells.

[0211] Example 13. Each joint window is divided into a first open window portion and a second open window portion, each of which is configured to receive different joint tabs of the joint, the first open window portion is formed between a central axially extending support and a first axial support arm connected to the lower end of the axially extending support and offset laterally in the circumferential direction relative to the periphery of the frame from the lower end of the axially extending support, and the second open window portion is axial A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 9 or Example 10, comprising a column extending in the axial direction and a second axial support arm connected to the lower end of the axially extending column and laterally offset from the lower end of the axially extending column, wherein each of the first axial support arm and the second axial support arm has an upper end that is free and configured to be displaceable laterally and radially with respect to the axially extending column in one or more directions.

[0212] Example 14. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 13, wherein the axially extending struts extend between an elongated strut joint at the bottom of the frame and an elongated strut joint at the top of the frame, the lower elongated strut joint being the joint between the first two oblique struts of two adjacent elongated cells and located at the outflow end of the frame, and the upper elongated strut joint being the joint between the second two oblique struts of two adjacent elongated cells and located at the opposite ends of the first two oblique struts and the two adjacent elongated cells.

[0213] Example 15. A prosthetic heart valve of any example herein, in particular any one of Examples 9-14, wherein the annular frame is radially expandable into an expandable configuration.

[0214] Example 16. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 15, wherein the expansion configuration has a diameter of 20 mm.

[0215] Example 17. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 15, wherein the expansion configuration has a diameter in the range of 19 to 21 mm.

[0216] Example 18. A prosthetic heart valve comprising an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells being positioned between the outflow and inflow ends of the frame and including an upper row of cells positioned at the outflow end, which is elongated axially with respect to the cells of the remaining rows of cells among the plurality of rows of cells, and the axial direction is with respect to the central longitudinal axis of the frame; and a plurality of leaflets positioned within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; the struts defining the upper row of cells being open at the upper end and further defining a plurality of open commissure windows formed between adjacent elongated cells of the upper row of cells, each commissure window being formed between two axially extending window struts spaced apart from each other in the circumferential direction, and each commissure window having a lower region configured to receive the commissure tab of the commissure and an upper region positioned at the outflow end of the frame.

[0217] Example 19. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 18, in which each of the two axially extending window supports defines the axial sides of two adjacent elongated cells in the upper row of cells.

[0218] Example 20. A prosthetic heart valve of any example herein, particularly one of the prosthetic heart valves of Examples 18-19, wherein each commissure window is closed at its lower end by a lateral window support portion connecting the lower ends of two axially extending window supports, the lower end being positioned opposite the upper end in the axial direction.

[0219] Example 21. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 20, wherein the lateral window support portion is further connected to an oblique support that defines a portion of the cells in a second row of cells adjacent to the upper row of cells.

[0220] Example 22. A prosthetic heart valve according to any example herein, particularly any one of Examples 18 to 21, wherein each axially extending window post of each commissure window comprises a lower window post portion and an upper window post portion, a first gap between the upper window post portions of the two axially extending window posts forms the upper region of the commissure window, and a second gap between the lower window post portions of the two axially extending window posts forms the lower region of the commissure window.

[0221] Example 23. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 22, wherein each upper window support portion is provided with a recess, and the first gap is larger than the second gap.

[0222] Example 24. A prosthetic heart valve of any example herein, particularly the prosthetic heart valves of Examples 22 and 23, further comprising a window fastener positioned within the upper region of each commissure window and configured to maintain a relatively constant distance between two axially extending window supports.

[0223] Example 25. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 24, wherein the window fastener comprises an intermediate portion and two opposing end portions, the intermediate portion extending between the two end portions, the two end portions having a width wider than the width of the intermediate portion, and the widths are arranged in the circumferential direction.

[0224] Example 26. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 25, wherein the intermediate portion is positioned within a first gap, the first of two end portions extends circumferentially between the radially outward-facing sides of the upper window support portion of two axially extending window supports, and the second of the two end portions extends circumferentially between the radially inward-facing sides of the upper window support portion.

[0225] Example 27. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 25, wherein the lateral edges of two end portions are provided with a plurality of notches adapted to receive a fastener inside.

[0226] Example 28. An annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows being positioned between the outflow end and the inflow end of the frame and being elongated axially with respect to the cells of the remaining rows of cells among the plurality of rows of cells, including the upper row of cells positioned at the outflow end, the axial direction being relative to the central longitudinal axis of the frame, and a plurality of valve leaflets located within the frame, each valve leaflet comprising a plurality of valve leaflets, each valve leaflet comprising a commissure tab facing the opposite side of the valve leaflet, each commissure tab being paired with the adjacent commissure tab of the adjacent valve leaflet to form a commissure, and struts defining the upper row of cells A prosthetic heart valve, which is open at its lower end and further defines multiple open commissure windows formed between adjacent elongated cells in the upper row of cells, each commissure window is formed by two axially extending window struts spaced apart in the circumferential direction and configured to receive a commissure inside, the two axially extending window struts are connected to an upward axial strut via the upper edge of the commissure window and to a downward oblique strut of the upper row of cells, and together the upward axial strut and the two axially extending window struts form an axially extending strut that defines the axial sides of each of two adjacent elongated cells.

[0227] Example 29. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 28, wherein the upper axial support and two axially extending window supports each extend axially, the upper edge of the commissure window extends perpendicularly to the upper axial support and circumferentially to the circumferential portion of the frame.

[0228] Example 30. A prosthetic heart valve of any example herein, particularly one of the prosthetic heart valves of Examples 28-29, wherein the upper edge is spaced apart from the outflow end of the frame by an upper axial support.

[0229] Example 31. A prosthetic heart valve of any example herein, particularly any one of Examples 28-30, wherein an upper axial support is positioned between an upper elongated support joint and an upper edge, the upper elongated support joint forming a joint between two oblique supports positioned at the outflow end of the frame, and each of the two oblique supports at least partially forms one upper side of each of two adjacent elongated cells.

[0230] Example 32. A prosthetic heart valve of any example herein, in particular any one of Examples 28-31, wherein each of the two axially extending window posts has a downward clamping portion, and the downward clamping portions of the two axially extending window posts are angled toward each other, defining an opening between them, the opening being a downward opening of a commissure window.

[0231] Example 33. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 32, wherein outward bends in the lower clamping portions of two axially extending window supports form a neck region configured to receive a fastener.

[0232] Example 34. An annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells being positioned between the outflow and inflow ends of the frame and including an upper row of cells positioned at the outflow end, which is elongated axially with respect to the cells of the remaining rows of cells among the plurality of rows of cells, and the axial direction is with respect to the central longitudinal axis of the frame, and a plurality of valve leaflets positioned within the frame, each valve leaflet comprising a plurality of valve leaflets, each valve leaflet comprising a plurality of valve leaflets, each valve leaflet comprising a commissure tab facing the opposite side of the valve leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent valve leaflet to form a commissure, the struts defining the upper row of cells further defining a plurality of open commissure windows, each commissure window being open at the upper end, and two A prosthetic heart valve, formed in the lower portion of adjacent elongated cells, between two adjacent elongated cells in the upper row of cells, with each commissure window divided into a first open window portion and a second open window portion, each of the first and second open window portions configured to receive different commissure tabs of the commissure, the first open window portion formed between a central axially extending strut and a first axial strut arm connected to the axially extending strut and laterally offset from the axially extending strut in the circumferential direction relative to the periphery of the frame, and the second open window portion formed between an axially extending strut and a second axial strut arm connected to the axially extending strut and laterally offset from the axially extending strut.

[0233] Example 35. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 34, wherein the axially extending struts extend between an elongated strut joint at the bottom of the frame and an elongated strut joint at the top of the frame, the lower elongated strut joint being the joint between the first two oblique struts of two adjacent elongated cells and located at the outflow end of the frame, and the upper elongated strut joint being the joint between the second two oblique struts of two adjacent elongated cells and located at the ends of the first two oblique struts and two adjacent elongated opposite cells.

[0234] Example 36. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 35, wherein the first axial support arm and the second axial support arm are positioned on opposite sides of an axially extending support and are connected to the axially extending support at the lower end of the axially extending support located at a lower elongated support joint.

[0235] Example 37. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 35, wherein each of the first axial support arm and the second axial support arm comprises an axial portion extending parallel to an axially extending support and a lateral portion extending between a lower elongated support joint and the axial portion.

[0236] Example 38. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 37, wherein the lateral portion is positioned perpendicular to the axial portion.

[0237] Example 39. A prosthetic heart valve of any example herein, particularly the prosthetic heart valves of Examples 37 and 38, wherein each of the first axial support arm and the second axial support arm has an upward clamping portion extending upward from the axial portion toward the outflow end of the frame, and the upward clamping portions of the first and second axial support arms form a narrower neck region at the open upper end of the commissure window.

[0238] Example 40. A prosthetic heart valve of any example herein, particularly one of the prosthetic heart valves of Examples 35-39, wherein each of the first axial support arm and the second axial support arm comprises a lower end that is directly connected to an axially extending support at a lower elongated support joint, and an upper end that is free and configured to be displaced laterally and / or radially relative to the axially extending support.

[0239] Example 41. Multiple interconnected struts defining multiple rows of cells, wherein the multiple rows of cells are positioned between the outflow end and inflow end of a frame, and include the outflow end of the cells positioned at the inflow end and the upper row of cells positioned in the lower row, the cells of the upper row of cells being elongated in the axial direction with respect to the central longitudinal axis of the frame with respect to the cells of the remaining rows of cells in the multiple rows of cells, including the lower row of cells, and multiple cross windows, each cross window being defined by a closed frame, the closed frame comprising a wider first portion and a narrower second portion, the first portion being connected to an elongated strut joint above the frame via a bendable strut portion, A prosthetic heart valve comprising an annular frame having multiple commissure windows, wherein the upper elongated strut joint is the joint between two oblique struts of two adjacent elongated cells in the upper row of cells, the axially extending struts are positioned between two adjacent elongated cells, and the commissure windows are configured to bend via their bendable strut portions from an extended configuration to a bent configuration in which the commissure windows overlap the axially extending struts; and a leaflet assembly having multiple leaflets, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, and each commissure being positioned within the respective second portion of the respective commissure window.

[0240] Example 42. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 41, wherein the upper elongated support joint is located at the outflow end of the frame, and the commissure window extends axially outward from the outflow end of the frame when in an extended configuration.

[0241] Example 43. A prosthetic heart valve of any example herein, particularly one of the prosthetic heart valves of Examples 41-42, wherein the bendable support portion is configured to bend from an extended configuration to a bent configuration via manual force, and the bendable support portion comprises a plastically deformable material.

[0242] Example 44. A prosthetic heart valve of any example herein, in particular any one of the prosthetic heart valves of Examples 41-43, wherein the bendable support portion is aligned axially with a support that extends axially.

[0243] Example 45. A prosthetic heart valve of any example herein, further comprising a wedge positioned within the first part, in particular one of the prosthetic heart valves of Examples 41-44.

[0244] Example 46. A prosthetic heart valve of any example herein, in particular one of the prosthetic heart valves of Examples 41-45, wherein the first part is shorter than the second part.

[0245] Example 47. A method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly, the step of bending the commissure window of the annular frame into a first bent configuration between a fully extended configuration and a fully bent configuration, wherein the commissure window is defined by a closed strut frame comprising a wider first portion and a narrower second portion, the first portion being connected to an upper elongated strut joint of the annular frame via a bendable strut portion, the upper elongated strut joint being a joint between two oblique struts of two adjacent elongated cells in an upper row of elongated cells located at the outflow end of the annular frame, the axially extending struts being located between two adjacent elongated cells, and in the fully extended configuration, the bendable strut portion A method comprising the steps of: inserting a commissure, at least partially pre-assembled outside the annular frame, into the commissure window, wherein the commissure window is not bent and extends outward from the outflow end of the annular frame in the axial direction with respect to the central longitudinal axis of the annular frame, and in a fully bent configuration, the commissure window overlaps an axially extending support; inserting a commissure into the commissure window, wherein the commissure window comprises a pair of commissure tabs fixed integrally to adjacently positioned valve leaflets of a valve leaflet assembly; bending the commissure window into a fully bent configuration such that the commissure window extends parallel to an axially extending support and is positioned radially inward of the axially extending support; and fixing the commissure window in the fully bent configuration to the annular frame.

[0246] Example 48. A method of any example herein, particularly the method of Example 47, wherein the step of fixing the commissar window to the annular frame includes the step of fixing the lateral edge of the second portion of the commissar window to the annular frame.

[0247] Example 49. The elongated cells in the upper column of the elongated cells are elongated relative to the cells in the remaining adjacent columns of the annular frame, and the remaining columns are positioned further from the outflow end than the upper column of the elongated cells, in any of the methods of any of the examples herein, particularly any one of Examples 47-48.

[0248] Example 50. A method of any example herein, particularly any one of Examples 47-49, wherein the step of inserting the crossbar includes first inserting the crossbar into a first portion of the support frame of the crossbar window, and then sliding the crossbar into a second portion of the support frame of the crossbar window.

[0249] Example 51. A method of any example herein, in particular any one of Examples 47-50, further comprising the step of inserting a wedge element into the first part of the joint window in order to further secure the joint within the second part of the joint window.

[0250] Example 52. A method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly, the step of inserting a commissure, at least partially pre-assembled on the outside of the annular frame, into a leaflet receiving window through an opening in a commissure support element, wherein the commissure comprises a pair of commissure tabs fixed integrally to adjacent leaflets of the leaflet assembly, the leaflet receiving window being open at a first end and formed by at least a portion of two axially extending members of a commissure support element connected at the opposite second end by a connecting member, the commissure support element being connected to the leaflet receiving window and the annular frame A method comprising: a step having a connecting portion adapted to connect to a portion of an annular frame forming two adjacent cells in an upper row of cells, the upper row of cells being located at the outflow end of an annular frame and having an elongated length in the axial direction with respect to the central longitudinal axis of the annular frame with respect to the cells in the remaining row of cells of the annular frame; and attaching a commissure support element to a portion of an annular frame such that a leaflet receiving window and a commissure disposed therein are located in the lower portion of the upper row of cells and an open area unobstructed from the leaflets is formed in the upper portion of the upper row of cells.

[0251] Example 53. A method according to any example herein, particularly the method of Example 52, wherein the step of attaching a commissure support element to a portion of an annular frame includes the steps of attaching the commissure support element to two adjacent cells and aligning a valve leaflet receiving window radially inward with respect to the central longitudinal axis of an axial support that forms a common axial side of each of the two adjacent cells.

[0252] Example 54. A method according to any example herein, particularly the method of Example 53, further comprising the step of securing a connecting member of a cross support element to a lower elongated post joint of an upper row of cells via one or more fasteners, wherein the lower elongated post joint is a joint between two oblique posts forming the lower edge of two adjacent cells and the lower end of an axial post.

[0253] Example 55. A method according to any example herein, particularly the method of Example 53 or Example 54, wherein the joint portion of the commissar support element comprises a pair of connecting members, each connected to one of two axially extending members by different curved members of the two curved members of the commissar support element.

[0254] Example 56. The step of attaching a cross-support element to a portion of an annular frame includes the step of hooking two curved members around the upper edge of two adjacent cells, the upper edge being located at the outflow end of the frame and formed by two oblique supports of the two adjacent cells, in any example of this specification, particularly the method of Example 55.

[0255] Example 57. A method according to any example herein, particularly the method of Example 56, further comprising the step of securing a commissure support element to an annular frame by fastening one or more fasteners around a pair of connecting members and the upper axial portions of two axially extending members of the commissure support element, wherein the upper axial portions extend from the lower axial portions of the two axially extending members, and the two lower axial portions form a valve leaflet receiving window.

[0256] Example 58. A method according to any example herein, particularly the method of Example 55, wherein the step of attaching a cross-support element to a portion of an annular frame includes the step of hooking two curved members around the lower lateral support portion of the support window through the central opening of the support window of the axial support, the support window being a closed window formed by a plurality of connected support portions including the lower lateral support portion, and positioned along the length of the axial support at a distance from the joint between the oblique supports of two adjacent cells forming the upper edge and upper end of the axial support.

[0257] Example 59. A method of any example herein, particularly the method of Example 58, wherein the step of attaching a cross-support element to an annular frame further includes the steps of: clamping two curved members toward each other while inserting a pair of connecting members through a central opening of a support window; and releasing the two curved members so that when the pair of connecting members is inserted through the central opening, the two curved members are biased laterally toward the inner edge of the axial support portion of the support window, so that the two curved members hook around the lower lateral support portion of the support window.

[0258] Example 60. An annular frame comprising a plurality of interconnected supports defining a plurality of rows of cells, the plurality of rows of cells being positioned between the outflow and inflow ends of the frame and including an upper row of cells positioned at the outflow end, which is axially elongated relative to the cells of the remaining rows of cells of the plurality of rows of cells, the axial direction being relative to the central longitudinal axis of the frame; and a plurality of leaflets positioned within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; and a commissure support element comprising a joint portion and at least one commissure support element having two axially extending members radially offset from the joint portion and spaced laterally apart from each other to form an open leaflet receiving window configured to receive a commissure, the joint portion being configured to join to the upper edges of two adjacent cells in the upper row of cells, the upper edges being positioned at the outflow end of the frame, and the leaflet receiving windows being spaced axially apart from the upper edges. Prosthetic heart valve.

[0259] Example 61. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 60, wherein the upper edges of two adjacent cells are formed by two oblique struts of the two adjacent cells, the lower ends of the two oblique struts are respectively connected to axial struts that form a common axial side of each of the two adjacent cells, and the axial struts are arranged parallel to the central longitudinal axis.

[0260] Example 62. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 61, wherein the leaflet receiving window is located radially inward of the axial support when the commissure support elements are coupled to the upper edges of two adjacent cells in the upper row of cells.

[0261] Example 63. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 62, wherein the axial support divides the leaflet receiving window into two open window portions, each of which is defined between the axial support and a different of two axially extending members, and each of which is configured to receive one of the opposing commissure tabs of the commissure.

[0262] Example 64. A prosthetic heart valve according to any example herein, particularly any one of Examples 60-63, wherein the connecting portion comprises a pair of connecting portions, each connected to one of two axially extending members by a different curved member of two curved members of a commissure support element, and when the connecting portion is connected to the upper edge of two adjacent cells, the pair of connecting members is positioned radially outward of the frame with respect to the central longitudinal axis, and the two axially extending members are positioned radially inward of the frame.

[0263] Example 65. The leaflet receiving window extends between two axially extending members and is further defined by a connecting member that forms a closed end at the first lower end of the leaflet receiving window, and the opposite upper second end of the leaflet receiving window is open and configured to receive a commissure through it, in a prosthetic heart valve of any example herein, in particular any one of Examples 60-64.

[0264] Example 66. A prosthetic heart valve of any example herein, particularly any one of Examples 60-65, wherein the connecting portion comprises a pair of connecting portions, each connected to one of two axially extending members by a different curved member of two curved members of a commissure support element, each curved member configured to curve and catch around the upper edges of two adjacent cells in an upper row of cells.

[0265] Example 67. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 66, wherein each of two axially extending members comprises an upward axial portion and a downward axial portion, each downward axial portion extending between a connecting member and a bend extending between the downward axial portion and the upward axial portion, each upward axial portion extending between its bend and the corresponding curved members of the two curved members, and a first width between the downward axial portions of the two axially extending members is wider than a second width between the upward axial portions of the two axially extending members, the second width being the width of the leaflet receiving window.

[0266] Example 68. A prosthetic heart valve of any example herein, particularly any one of Examples 60-67, wherein the commissure support element is fixed to the frame via one or more fasteners.

[0267] Example 69. An annular frame comprising multiple interconnected pillars defining multiple columns of cells, wherein the multiple columns are located between the outflow and inflow ends of the frame and include an upper column of cells located at the outflow end, which is axially elongated relative to the cells of the remaining columns of cells, and the pillars defining the upper column of cells are comprised of multiple axial pillars, each axial pillar forming a common axial side of two adjacent cells in the upper column of cells, a portion of the multiple axial pillars being a window axial pillar, each window axial pillar extending along the length of the window axial pillar from the upper end of the window axial pillar A prosthetic heart valve comprising: an annular frame having a closed support window positioned at a certain distance apart; a plurality of leaflets located within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; and at least one commissure support element having a coupling portion and two axially extending members radially offset from the coupling portion and spaced laterally apart from each other to form an open leaflet receiving window configured to receive a commissure, the coupling portion configured to coupling with the support window.

[0268] Example 70. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 69, wherein when the commissure support element is coupled to the column window of the window axial column, the leaflet receiving window is positioned immediately radially inward of the lower column portion of the window axial column, the column window portion is positioned between the lower and upper column portions of the window axial column, the lower column portion is connected to oblique columns forming the lower edges of two adjacent cells in the upper row of cells, and the upper column portion is connected to oblique columns forming the upper edges of two adjacent cells.

[0269] Example 71. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 70, wherein the length of the upper support portion is shorter than the length of the lower support portion, and the length of the lower support portion corresponds to the leaflet receiving window of the commissure support element.

[0270] Example 72. A prosthetic heart valve of any example herein, particularly any one of Examples 69-71, wherein when the commissure support element is coupled to the support window, a distance is selected at which the closed support window is spaced from the upper end of the support in the window axis direction, such that the leaflet receiving window is positioned closer to the lower ends of two adjacent cells than to the upper ends of two adjacent cells, and the upper end is positioned at the outflow end of the annular frame.

[0271] Example 73. A prosthetic heart valve according to any example herein, particularly any one of Examples 69 to 72, wherein the connecting portion of the commissure support element comprises a pair of connecting members radially offset from two axially extending members, the pair of connecting members comprising a first connecting member coupled to a first axial member of the two axially extending members by a first curved member, and a second connecting member coupled to a second axial member of the two axially extending members by a second curved member.

[0272] Example 74. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 73, wherein the support window comprises a plurality of connected support portions defining a central opening of the support window, and the width of the central opening is sized to accommodate first and second curved members.

[0273] Example 75. A prosthetic heart valve according to any of the examples herein, particularly the prosthetic heart valve of Example 74, wherein the width of the central opening is less than or equal to the free state distance between the outer edges of the first curved member and the outer edges of the second curved member.

[0274] Example 76. A plurality of interconnected struts defining a plurality of columns of cells, the plurality of columns being disposed between an outflow end and an inflow end of a frame, the outflow end of cells disposed at the inflow end and an upper column of cells disposed below, the cells of the upper column of cells being elongated axially with respect to the central longitudinal axis of the frame relative to the cells of the remaining columns of cells of the plurality of columns of cells including the lower column of cells, and a plurality of crosslinking windows formed between window struts extending axially of the frame, each crosslinking window being disposed between axially extending window struts of two adjacent elongated cells of the upper column of open cells, each crosslinking window having a crosslinking receiving portion spaced from the upper ends of the two adjacent elongated cells, the upper ends being disposed at the outflow end of the frame, an annular frame comprising the plurality of crosslinking windows, and a cusp assembly comprising a plurality of cusps, each cusp having opposing crosslinking tabs on opposing sides of the cusp, each crosslinking tab being paired with an adjacent crosslinking tab of an adjacent cusp to form a crosslink, each crosslink being disposed within the crosslinking receiving portion of its respective crosslinking window, and when each crosslink is disposed within the crosslinking receiving portion of its respective crosslinking window, the crosslink is disposed within the lower portion of the upper column of cells and an open region unobstructed by the cusps is formed within the upper portion of the upper column of cells, the upper portion being disposed closer to the outflow end than the lower portion, a prosthetic heart valve comprising the cusp assembly.

[0275] Example 77. A plurality of interconnected struts defining a plurality of columns of cells, the plurality of columns being disposed between an outflow end and an inflow end of a frame, and including an outflow end of a cell disposed at the inflow end and an upper column of cells disposed at a lower column of cells; and a plurality of cross-connecting windows formed between axially extending window struts of the frame, each cross-connecting window being disposed between axially extending window struts of two adjacent cells of an upper column of open cells, each cross-connecting window having a cross-connecting receiving portion spaced from upper ends of the two adjacent cells, the upper ends being disposed at the outflow end of the frame, and each cross-connecting window having an open end; an annular frame including the plurality of cross-connecting windows; and a valve cusp assembly including a plurality of valve cusps, each valve cusp having opposing cross-connecting tabs on opposing sides of the valve cusp, each cross-connecting tab being paired with an adjacent cross-connecting tab of an adjacent valve cusp to form a cross-connect, each cross-connect being disposed within the cross-connecting receiving portion of a respective cross-connecting window, and the open end of the cross-connecting window being configured to receive the cross-connect through the open end; a prosthetic heart valve comprising the valve cusp assembly.

[0276] Example 78. The open ends of each cross-connecting window are formed by upper or lower ends of axially extending window struts that are circumferentially spaced from each other and not directly connected to each other, the circumferential direction being with respect to the circumferential portion of the frame and being disposed axially adjacent; a prosthetic heart valve of any of the examples herein, particularly the prosthetic heart valve of Example 77.

[0277] Example 79. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 77 or Example 78, wherein each commissure window is formed between a window post extending in the first axial direction of a first cell of two adjacent cells and a window post extending in the second axial direction of a second cell of two adjacent cells, the first axial window post and the second axial window post are spaced apart from each other along the length of their respective windows posts at their upper ends and connected to each other at their lower ends by a lateral window post portion, each of the first axial window post and the second axial window post comprises a lower window post portion and an upper window post portion, and the commissure receiving portion of the commissure is formed in the space between the lower window post portion of the first axial window post and the lower window post portion of the second axial window post.

[0278] Example 80. Each interlocking window is formed between a window support extending in a first axial direction and a window support extending in a second axial direction, and the first and second axial window supports are spaced apart from each other in the circumferential direction along the length of their respective lower ends, and the lower ends of the first and second axial window supports are connected to the corresponding lower oblique supports of one of the two adjacent cells. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 77 or Example 78, wherein a first axially extending window post and a second axially extending window post are connected to each other and connected at their upper ends to an axially extending window post via the upper edge of a commissure window extending in the circumferential direction, the axially extending window post being connected at its upper end to an axially extending junction that forms a joint between two adjacent obliquely extending cells.

[0279] Example 81. Each joint window is divided into a first open window portion and a second open window portion, each of the first and second open window portions is configured to receive different joint tabs of the joint, the first open window portion is formed between a central axially extending support and a first axial support arm connected to the lower end of the axially extending support and offset laterally in the circumferential direction relative to the periphery of the frame from the lower end of the axially extending support, and the second open window portion is axially A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 77 or Example 78, comprising an extending column and a second axial support arm connected to the lower end of the axially extending column and laterally offset from the lower end of the axially extending column, wherein each of the first axial support arm and the second axial support arm has an upper end that is free and configured to be displaceable laterally and radially with respect to the axially extending column in one or more directions.

[0280] Example 82. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 81, wherein the axially extending struts extend between a lower strut joint of the frame and an upper strut joint of the frame, the lower strut joint being the joint between two first oblique struts of two adjacent cells and located at the outflow end of the frame, and the upper strut joint being the joint between two second oblique struts of two adjacent cells and located at the ends of two adjacent cells opposite to the first two oblique struts.

[0281] Example 83. A prosthetic heart valve of any example herein, particularly one of the prosthetic heart valves of Examples 77-82, wherein the annular frame is radially expandable into an expandable configuration.

[0282] Example 84. A prosthetic heart valve of any example herein, particularly one of the prosthetic heart valves of Examples 77-83, wherein the cells in the upper column of the cell are elongated in the axial direction relative to the cells in the lower column of the cell.

[0283] Example 85. A prosthetic heart valve comprising an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows of cells being located between the outflow end and the inflow end of the frame and including an upper row of cells located at the outflow end; and a plurality of leaflets located within the frame, each leaflet having a commissure tab facing the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; the struts defining the upper row of cells being open at the upper end and further defining a plurality of open commissure windows formed between adjacent cells of the upper row of cells, each commissure window being formed between two axially extending window struts spaced apart from each other in the circumferential direction, each commissure window having a lower region configured to receive the commissure tab of the commissure.

[0284] Example 86. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 85, in which each of the two axially extending window supports defines the axial sides of two adjacent cells in the upper row of cells.

[0285] Example 87. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 85 or Example 86, wherein each commissure window is closed at its lower end by a transverse window support portion connecting the lower ends of two axially extending window supports, the lower end being positioned opposite the upper end in the axial direction.

[0286] Example 88. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 87, wherein the lateral window support portion is further connected to an oblique support that defines a portion of the cells in a second row of cells positioned adjacent to the upper row of cells.

[0287] Example 89. A prosthetic heart valve of any example herein, particularly any one of Examples 85-88, wherein each axially extending window post of each commissure window comprises a lower window post portion and an upper window post portion, a first gap between the upper window post portions of the two axially extending window posts forms the upper region of the commissure window, a second gap between the lower window post portions of the two axially extending window posts forms the lower region of the commissure window, each upper window post portion includes a recess, and the first gap is larger than the second gap.

[0288] Example 90. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 89, further comprising a window fastener positioned within the upper region of each commissure window and configured to maintain a relatively constant distance between two axially extending window supports.

[0289] Example 91. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 90, wherein the window fastener comprises an intermediate portion and two opposing end portions, the intermediate portion extending between the two end portions, the two end portions having a width wider than the width of the intermediate portion and the widths arranged in the circumferential direction, the intermediate portion being positioned within a first gap, the first end portion of the two end portions extending circumferentially between the radially outward-facing sides of the upper window support portion of two axially extending window supports, and the second end portion of the two end portions extending circumferentially between the radially inward-facing sides of the upper window support portion.

[0290] Example 92. A prosthetic heart valve comprising an annular frame having a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows being positioned between the outflow and inflow ends of the frame and including an upper row of cells positioned at the outflow end; and a plurality of leaflets positioned within the frame, each leaflet having a commissure tab opposite to the opposite side of the leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; and struts defining the upper row of cells further defining a plurality of open commissure windows formed between adjacent cells of the upper row of cells, each commissure window being formed by two axially extending window struts configured to receive a commissure and spaced apart from each other in the circumferential direction, the commissure windows being axially offset toward the upstream / inflow end of the upper row of cells.

[0291] Example 93. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 92, wherein two axially extending window struts are connected to an upward axial strut via the upper edge of a commissure window and to a downward oblique strut of the upper row of cells, and the upward axial strut and the two axially extending window struts together form an axially extending frame portion defining the axial sides of each of two adjacent cells.

[0292] Example 94. A prosthetic heart valve according to any example herein, particularly the prosthetic heart valve of Example 93, wherein the upper axial support and two axially extending window supports extend axially, the upper edge of the commissure window extends perpendicularly to the upper axial support and circumferentially to the circumferential portion of the frame.

[0293] Example 95. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 93 or Example 94, wherein the upper edge is spaced apart from the outflow end of the frame by an upper axial support.

[0294] Example 96. A prosthetic heart valve of any example herein, particularly the prosthetic heart valve of Example 95, wherein the length of the upper axial support is selected such that the axial distance between the outflow end of the frame and the outflow edges of the multiple leaflets is in the range of 2 to 3 mm.

[0295] Example 97. The upper axial strut is disposed between the upper strut junction and the upper edge, and the upper strut junction forms a junction between two diagonal struts disposed at the outflow end of the frame. Each diagonal strut of the two diagonal struts at least partially forms one upper side portion of two adjacent cells. It is a patch heart valve of any example herein, particularly any one of the patch heart valves of Examples 93 to 96.

[0296] Example 98. Each communicating window is open at its lower end. Each axially extending window strut of the two axially extending window struts has a lower clamping portion. The lower clamping portions of the two axially extending window struts are inclined towards each other and define an opening therebetween. The opening is the lower opening of the communicating window. It is a patch heart valve of any example herein, particularly any one of the patch heart valves of Examples 93 to 97.

[0297] Example 99. The outward bending in the lower clamping portions of the two axially extending window struts forms a collar region configured to receive a fastener. It is a patch heart valve of any example herein, particularly the patch heart valve of Example 98.

[0298] Considering the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the disclosed technology and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Description of Reference Numerals

[0299] 10 Patch heart valve 12 Stent, frame 14 Valve structure 15 Inflow end portion 16 Inner skirt 17 Intermediate portion 18 Valve peripheral outer sealing member, outer skirt 19 Outflow end portion 20 slots, cross-connected windows 22 commissure 40 leaflets 50 frames 52 Inlet end 54 Outlet end 56. Central longitudinal axis 58 Interconnected windows 60. Diagonal support pillars 62. Diagonal support 64. Lower diagonal support, lower support joint, lower elongated support joint 66 Upper diagonal support, upper support joint, upper elongated support joint 68 Interconnected window frame section, support section 70 Columns extending in the axial direction 72, 74 aperture 76 Long, narrow opening 80 commissure 82a First interlocking tab 82b Second communal tab 84a First leaflet 84b Second valve leaflet 86 Upper area 88 Lower area 100 frames 102 Open-type connecting window 104a Window support extending in the first axial direction 104b Window support extending in the second axial direction 106a First elongated cell 106b Second elongated cell 108 Distance, gap 110 commissure 112a, 112b Lower (or distal) window support section 113 Horizontal window support section 114a, 114b Upper (or proximal) window support section 116 Upper area 118 Lower region, commissure receiving part 120 Height of connecting tabs 82a, 82b 122 Edge of the undulating surface 124 Upper edge 128 Length of lower window support sections 112a and 112b 130 Length of upper window support sections 114a and 114b 132 Concave part 134 No-load distance 140 Lower part 142 Upper part 150 Interlocking window fasteners 152 Middle part 154 First end portion 156 Second end portion 158 Width of end sections 154 and 156 160, width of the middle section 152 162 Lateral edge 164 notches, indentations 166 Sutures 200 frames 202 Open-type connecting window 204a Window support extending in the first axial direction 204b Window support extending in the second axial direction 205 Length of window support columns 204a and 204b extending in the axial direction 206a, 206b Elongated cells 207 Length of axial support column 70 208 Upper axial column 210 Upper elongated support joint 212 Upper edge 214a, 214b Lower tightening section 216 commissure 218 Aperture 220 sutures 250 axial distance 252 Length of the upper axial support column 208 300 frames 302 Open-type connecting window 304a First open window section 304b Second open window section 306a, 306b Elongated cells 308a First axial support arm 308b Second axial support arm 310 Lower elongated support joint 311 Upper elongated support joint 312a, 312b Lateral part 314a, 314b Axial section 316 Axial strut 318a First upper clamping portion 318b Second upper clamping portion 320 commissure 322a, 322b First tab section 324a, 324b Second tab section 326a, 326b Third tab section 340a First depression 340b Second depression 342 Axial extension 344a, 344b Reinforcement members 346a, 346b sutures 348a, 348b Fabric pieces 350 sutures 360 distance 362 width under no load 400 frames 402 Interconnecting window 404 Support Frame 406 The first part, which is wider The second part, which is thinner than 408. 410 Flexible support section 412a First elongated cell 412b Second elongated cell 414 Upper elongated support joint 416 First length 418 First width 420 Second length 422 Second width 424 Commissure 426 Lateral edge 428 Lower strut joint 430 Lateral edge 432 Suture thread 436 Upper edge 600 frames 602 Commisural support elements 604 Integrated wire-type main body 606 Joining part 608 Valve leaflet receiving window 610 First axial member 612 Second axial member 614 Connecting member 616, 618 Connecting members 620 commissure 622, 624 Curved section, curved member 626 Upper axial section 628 Lower axial section 630 bend 632 Width between the downward axial portions 628 634 Width between upper axial portions 626 640 Distal end 642 cells 644 Proximal end 646 elongated cells 648 Upper edge 650a First window section 650b Second window section 652 First fastener 654 Lower strut joint 656 Second fastener 658 axial length 660 Axial support column length 70 662 Axial strut 664 Axial support column 662 Thickness 666 Axial strut 668 Thickness of axial support column 666 670 Lower area 672 Upper area 700 frames 702 Window axis support column 704 Pillar window 706 Upper elongated support joint 708 Lower elongated support joint 710 Commisural support elements 714 Upper support section 716 Lower support section 718 First lateral support section 720 Second lateral support section 722 First axial support section 724 Second axial support section 726 Central opening 728 First length 730 Second length 732 Wire-type main unit 734 Valve leaflet receiving window 734a First window section 734b Second window section 736 First axial member 738 Second axial member 740 Connecting member 742, 744 Connecting members 746, 748 Curved section, curved member 752 First fastener 800 Delivery Device 802 Handle 804 Outer shaft 806 Intermediate shaft 808 Inner shaft 810 Proximal end portion 812 Adapter 814 Rotatable Knob 818 Inflatable Balloons 820 Central longitudinal axis 822 Nose Cone 824 Valve mounting section 826 Distal shoulder 828 Distal tip 838 First port 840 Second port 850 Prosthetic heart valve 860° rotatable knob 861 Adjustment mechanism 862 Rotatable Knob 878 Rotatable Knob I. First column II. Second column III The third column IV (Fourth Column)

Claims

1. It is a ring-shaped frame, A plurality of interconnected support columns defining a plurality of columns of cells, wherein the plurality of columns are positioned between the outflow end and the inflow end of the frame, and include a column above the cells positioned at the outflow end and a column below the cells positioned at the inflow end, and A plurality of interlocking windows formed between window posts extending axially in the frame, each interlocking window positioned between window posts extending axially in the upper row of the cell, each interlocking window having an interlocking receiving portion spaced apart from the upper ends of the two adjacent cells, the upper ends being positioned at the outflow end of the frame, and each interlocking window having an open end. A frame having, A valve leaflet assembly comprising multiple valve leaflets, each valve leaflet having a commissure tab facing the opposite side of the valve leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent valve leaflet to form a commissure, each commissure being positioned in the commissure receiving portion of the commissure window, and the open end of the commissure window being configured to receive the commissure through the open end, and Equipped with, Each connecting window is formed between a window post extending in the first axial direction of the first cell of the two adjacent cells and a window post extending in the second axial direction of the second cell of the two adjacent cells, the first axially extending window post and the second axially extending window post are spaced apart from each other along the length of the window posts at their upper ends and connected to each other at their lower ends by a lateral window post portion, each of the first axially extending window post and the second axially extending window post comprises a lower window post portion and an upper window post portion, the connecting receiving portion is formed in the space between the lower window post portion of the first axially extending window post and the lower window post portion of the second axially extending window post, The frame further comprises a clamping portion at the open end of the commissure window, wherein the prosthetic heart valve.

2. The prosthetic heart valve according to claim 1, wherein the open end of each commissure window is formed by the upper or lower end of the axially extending window posts that are spaced apart from each other in the circumferential direction and not directly connected to each other, the circumferential direction being relative to the circumferential portion of the frame and arranged in contact with the axial direction.

3. It is a ring-shaped frame, A plurality of interconnected support columns defining a plurality of columns of cells, wherein the plurality of columns are positioned between the outflow end and the inflow end of the frame, and include a column above the cells positioned at the outflow end and a column below the cells positioned at the inflow end, and A plurality of interlocking windows formed between window posts extending axially in the frame, each interlocking window positioned between window posts extending axially in the upper row of the cell, each interlocking window having an interlocking receiving portion spaced apart from the upper ends of the two adjacent cells, the upper ends being positioned at the outflow end of the frame, and each interlocking window having an open end. A frame having, A valve leaflet assembly comprising multiple valve leaflets, each valve leaflet having a commissure tab facing the opposite side of the valve leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent valve leaflet to form a commissure, each commissure being positioned in the commissure receiving portion of the commissure window, and the open end of the commissure window being configured to receive the commissure through the open end, and Equipped with, Each interlocking window is formed between a window support extending in a first axial direction and a window support extending in a second axial direction, and the first and second axial window supports are spaced apart from each other in the circumferential direction along the length of their respective lower ends, and the lower ends of each of the first and second axial window supports are connected to the corresponding lower diagonal support of one of the two adjacent cells, and the first and second axial window supports are connected to each other and, via the upper edge of the circumferentially extending interlocking window, are connected to an upper axial support at their upper ends, and the upper axial support is connected at its upper end to an upper support joint that forms a joint between the upper diagonal supports of the two adjacent cells, The frame further comprises a clamping portion at the open end of the commissure window, wherein the prosthetic heart valve.

4. It is a ring-shaped frame, A plurality of interconnected support columns defining a plurality of columns of cells, wherein the plurality of columns are positioned between the outflow end and the inflow end of the frame, and include a column above the cells positioned at the outflow end and a column below the cells positioned at the inflow end, and A plurality of interlocking windows formed between window posts extending axially in the frame, each interlocking window positioned between window posts extending axially in the upper row of the cell, each interlocking window having an interlocking receiving portion spaced apart from the upper ends of the two adjacent cells, the upper ends being positioned at the outflow end of the frame, and each interlocking window having an open end. A frame having, A valve leaflet assembly comprising multiple valve leaflets, each valve leaflet having a commissure tab facing the opposite side of the valve leaflet, each commissure tab being paired with an adjacent commissure tab of an adjacent valve leaflet to form a commissure, each commissure being positioned in the commissure receiving portion of the commissure window, and the open end of the commissure window being configured to receive the commissure through the open end, and Equipped with, Each joint window is divided into a first open window portion and a second open window portion, each of the first and second open window portions is configured to receive different joint tabs of the joint, the first open window portion is formed between a central axially extending support and a first axial support arm connected to the lower end of the axially extending support and shifted laterally in the circumferential direction relative to the periphery of the frame from the lower end of the axially extending support, the second open window portion is formed between the axially extending support and a second axial support arm connected to the lower end of the axially extending support and shifted laterally from the lower end of the axially extending support, each of the first axial support arm and the second axial support arm has an upper end that is free and configured to be displaced laterally and radially relative to the axially extending support, The frame further comprises a clamping portion at the open end of the commissure window, wherein the prosthetic heart valve.

5. The axially extending support extends between a lower support joint of the frame and an upper support joint of the frame, the lower support joint being a joint between two first diagonal supports of the two adjacent cells and located at the outflow end of the frame, and the upper support joint being a joint between two second diagonal supports of the two adjacent cells and located at the end of the two adjacent cells opposite to the first two diagonal supports, according to claim 4.

6. The prosthetic heart valve according to any one of claims 1 to 5, wherein the annular frame is radially expandable into an expandable configuration.

7. An annular frame comprising a plurality of interconnected pillars defining a plurality of columns of cells, wherein the plurality of columns of cells are positioned between the outflow end and the inflow end of the frame, and include the upper column of cells positioned at the outflow end, A plurality of valve leaflets located within the frame, each valve leaflet having a commissure tab facing the opposite side of the valve leaflet, and each commissure tab being paired with an adjacent commissure tab of an adjacent valve leaflet to form a commissure, and Equipped with, The support columns defining the upper row of the cell are open at their upper ends, further defining a plurality of open commissar windows formed between adjacent cells in the upper row of the cell, each commissar window formed between two axially extending window columns spaced apart from each other in the circumferential direction, and each commissar window comprises a lower region configured to receive the commissar tab of the commissar, The frame further includes a fastening portion at the upper end of the connecting window, A prosthetic heart valve in which each of the two axially extending window supports defines the axial sides of two adjacent cells in the upper row of the cell.

8. Each commissure window is closed at its lower end by a lateral window support portion connecting the lower ends of the two axially extending window supports, the lower end being positioned opposite the upper end in the axial direction, as described in claim 7.

9. The prosthetic heart valve according to claim 8, wherein the lateral window support portion is further connected to an oblique support that defines a portion of the cells in a second row of cells arranged adjacent to the upper row of cells.

10. A prosthetic heart valve according to any one of claims 7 to 9, wherein each of the two axially extending window supports of each commissure window comprises a lower window support portion and an upper window support portion, a first gap between the upper window support portions of the two axially extending window supports forms the upper region of the commissure window, a second gap between the lower window support portions of the two axially extending window supports forms the lower region of the commissure window, each upper window support portion includes a recess, and the first gap is larger than the second gap.

11. The prosthetic heart valve according to claim 10, further comprising a window fastener positioned within the upper region of each commissure window and configured to maintain a relatively constant distance between the two axially extending window supports.

12. The prosthetic heart valve according to claim 11, wherein the window fastener comprises an intermediate portion and two opposing end portions, the intermediate portion extending between the two end portions, the two end portions having a width wider than the width of the intermediate portion, the width being arranged in the circumferential direction, the intermediate portion being positioned within the first gap, the first end portion of the two end portions extending circumferentially between the radially outward-facing sides of the upper window support portion of the two axially extending window supports, and the second end portion of the two end portions extending circumferentially between the radially inward-facing sides of the upper window support portion.

13. The prosthetic heart valve according to any one of claims 1 to 12, wherein the commissure window is axially offset toward the inflow end of the upper row of cells.

14. The prosthetic heart valve according to claim 13, wherein the two axially extending window supports are connected to an upward axial support via the upper edge of the commissure window and to a downward oblique support of the upper row of cells, and the upward axial support and the two axially extending window supports together form an axially extending frame portion defining the axial sides of each of two adjacent cells.

15. The prosthetic heart valve according to claim 14, wherein the upper axial support and the two axially extending window supports each extend in the axial direction, the upper edge of the commissure window extends perpendicularly to the upper axial support, and the circumferential direction is relative to the circumferential portion of the frame.

16. The prosthetic heart valve according to claim 14 or 15, wherein the upper edge is spaced apart from the outflow end of the frame by the upper axial support.

17. The length of the upper axial support is selected such that the axial distance between the outflow end of the frame and the outflow edges of the plurality of valve leaflets is in the range of 2 to 3 mm, as described in claim 16.

18. The prosthetic heart valve according to any one of claims 14 to 17, wherein the upper axial support is positioned between the upper support joint and the upper edge, the upper support joint forms a joint between two oblique supports positioned at the outflow end of the frame, and each of the two oblique supports forms at least partially the upper side of one of the two adjacent cells.

19. The prosthetic heart valve according to any one of claims 14 to 18, wherein each commissure window is open at its lower end, each of the two axially extending window posts is provided with a lower clamping portion, the lower clamping portions of the two axially extending window posts are angled toward each other, defining an opening between them, the opening being the lower opening of the commissure window.

20. The prosthetic heart valve according to claim 19, wherein the outward bends in the downward tightening portions of the two axially extending window supports form a neck region configured to receive a fastener.

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