Leaflet commissure assembly for a prosthetic heart valve and method of assembly

Abstract

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

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 003,085, filed March 31, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to prosthetic heart valves comprising a frame having rows of elongated cells, and to methods and assemblies for forming commissures with leaflets of such prosthetic heart valves. Background Technology

[0004] The human heart can suffer from various valvular diseases. These valvular diseases can lead to serious cardiac dysfunction, ultimately requiring repair of the natural valve or replacement with an artificial valve. There are various known repair devices (e.g., stents) and artificial valves, as well as various known methods for implanting these devices and valves into the body. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where access is desired without surgery. In a specific example, a prosthetic heart valve can be crimped and mounted on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies expansion force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device, allowing the prosthetic valve to self-expand to its functional size.

[0005] Prosthetic valves that expand using mechanical actuators can be referred to as "mechanically expandable" prosthetic heart valves. The actuators are typically in the form of traction cables, sutures, threads, and / or shafts configured to transmit expansion force from the handle of the delivery device to the prosthetic valve.

[0006] Most expandable transcatheter heart valves comprise a cylindrical metal frame or stent and a prosthetic leaflet housed within the frame. The leaflet can be attached to the frame at commissure tabs. For example, the commissure can be formed by connecting the commissure tabs of two adjacent leaflets to each other, or in some embodiments, by connecting to a flexible sheet or attachment member configured to attach to a commissure support portion of the frame. The commissure can then be attached to the commissure support portion of the frame via fasteners such as sutures.

[0007] Transcatheter heart valves typically use medium to high dilation diameters, such as in the range of 23 to 29 mm. Smaller diameter valves, such as 20 mm prosthetic valves, are used less frequently due to various challenges posed by their smaller frame unit size. For example, the smaller units of such a frame may interfere with blood flow into the coronary ostium after a valve-in-valve (e.g., a prosthetic valve-in-a-prosthetic) procedure. As another example, after valve implantation, smaller units may at some later time prevent optional coronary re-access devices from passing through them.

[0008] To at least partially address these issues, the upper row of units in the frame positioned near the outflow end of the prosthetic valve frame may be elongated relative to the other rows of units in the frame. However, the leaflet assembly of the prosthetic valve, including the ferrule attached to the frame, may at least partially obstruct the opening of the upper row of units, thereby reducing blood flow and the access to the coronary reentry device.

[0009] Therefore, an improved prosthetic heart valve and commissure attachment assembly is needed, which holds the leaflet of the prosthetic valve in a lower position within the frame. This lower position maintains a unit region within the upper unit with a relatively open opening near the outflow end of the frame, thereby allowing increased blood flow to the coronary ostium and passage of the coronary reentry device after the prosthetic valve is implanted. Summary of the Invention

[0010] This document describes embodiments of prosthetic heart valves and methods for assembling prosthetic heart valves comprising an annular frame and leaflet assemblies. In some embodiments, at least partially pre-assembled commissures, each comprising paired commissure lugs of adjacent leaflets of the leaflet assembly, may be arranged within a commissure window of the annular frame or a commissure support element configured to engage with a portion of the annular frame configured to receive the commissure support element. The commissure window, the portion of the annular frame configured to receive the commissure support element, and / or the commissure support element may be configured to position the commissure within a lower portion of an upper elongation unit of the annular frame.

[0011] In one representative embodiment, a method of assembling a prosthetic heart valve comprising an annular frame and leaflet assemblies includes inserting a pre-assembled commissure, pre-attached to the outside of the annular frame, into a commissure window of the frame via an opening in an upper or lower portion of the commissure window. The commissure includes commissure lugs of adjacent leaflets of the leaflet assembly, secured together in pairs. Each commissure window is formed by one or more axially extending struts of two adjacent units in an upper row of units of the frame, the upper row of units being arranged at the outflow end of the frame and having an elongated length relative to the units in the remaining rows of units of the frame in an axial direction relative to the central longitudinal axis of the frame. The method further includes securing the commissure within a commissure receiving portion of the commissure window via one or more fasteners, such that the commissure is arranged within a lower portion of the upper row of units and an open area unobstructed by leaflets is formed within the upper portion of the upper row of units, the upper portion being arranged closer to the outflow end than the lower portion.

[0012] In another representative embodiment, the prosthetic heart valve includes: an annular frame comprising a plurality of interconnected struts defining multiple rows of units arranged between an outflow end and an inflow end of the frame and including an upper row of units arranged at the outflow end and a lower row of units arranged at the inflow end. The annular frame also includes a plurality of connecting windows formed between axially extending window struts of the frame, each connecting window being arranged between axially extending window struts of two adjacent units in the upper open row, each connecting window having: a connecting receiving portion spaced from the upper ends of the two adjacent units, the upper end of which is arranged at the outflow end of the frame; and an open end. The prosthetic heart valve also includes a leaflet assembly comprising a plurality of leaflets, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural portion, wherein each commissural portion is disposed within a commissural receiving portion of a corresponding commissural portion window, and wherein the open end of the commissural portion window is configured to receive a commissural portion passing through it.

[0013] In some embodiments, the units in the upper row are elongated relative to the units in the remaining rows of units, including the lower row, in an axial direction relative to the central longitudinal axis of the frame.

[0014] In another representative embodiment, the prosthetic heart valve includes: an annular frame comprising a plurality of interconnected struts defining a multi-row unit, the multi-row unit being disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end that extends axially relative to the units in the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame. The prosthetic heart valve also includes a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissure. The struts defining the upper row unit further define a plurality of open commissural windows, the plurality of open commissural windows being open at their upper ends and formed between adjacent elongated units in the upper row unit, each commissural window being formed between two axially extending window struts spaced apart from each other in a circumferential direction, each commissural window including a lower region of a commissural lug configured to receive a commissure and an upper region disposed at the outflow end of the frame.

[0015] In another representative embodiment, the prosthetic heart valve includes an annular frame comprising a plurality of interconnected struts defining multiple rows of units arranged between an outflow end and an inflow end of the frame, and including an upper row of units arranged at the outflow end that extends axially relative to the units in the remaining rows of units, the axial direction being relative to the central longitudinal axis of the frame. The prosthetic heart valve also includes a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissure. The pillars defining the upper row unit also define a plurality of open connecting windows. The plurality of open connecting windows are open at their lower ends and are formed in the lower portion of the adjacent elongated units between adjacent elongated units in the upper row unit. Each connecting window is configured to receive the connecting portion therein and is formed by two axially extending window pillars spaced apart from each other in the circumferential direction. The two axially extending window pillars are connected to the upper axial pillar via the upper edge of the connecting window and to the lower angled pillar of the upper row unit. The upper axial pillar and the two axially extending window pillars together form an axially extending pillar, which defines the axial side of each of the two adjacent elongated units.

[0016] In another representative embodiment, the prosthetic heart valve includes an annular frame comprising a plurality of interconnected struts defining a multi-row unit. The multi-row unit is arranged between an outflow end and an inflow end of the frame and includes an upper row unit arranged at the outflow end that extends axially relative to the units in the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame. The prosthetic heart valve also includes a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissure. The pillars defining the upper row of units also define a plurality of open connecting windows, each connecting window being open at its upper end and formed within the lower portion of two adjacent elongated units in the upper row of units. Each connecting window is divided into a first open window portion and a second open window portion, each of the first open window portion and the second open window portion being configured to receive a different one of the connecting lugs of the connecting portion therein. The first open window portion is formed between a central axially extending pillar and a first axial pillar arm, the first axial pillar arm being connected to the axially extending pillar in a circumferential direction relative to the circumference of the frame and laterally offset from the axially extending pillar. The second open window portion is formed between the axially extending pillar and the second axial pillar arm, the second axial pillar arm being connected to the axially extending pillar and laterally offset from the axially extending pillar.

[0017] In another representative embodiment, the prosthetic heart valve includes an annular frame comprising a plurality of interconnected struts defining a multi-row unit arranged between an outflow end and an inflow end of the frame and including an upper row unit arranged at the outflow end and a lower row unit arranged at the inflow end, wherein the units in the upper row unit are elongated relative to the units in the remaining rows of units, including the lower row unit, in an axial direction relative to the central longitudinal axis of the frame. The annular frame further includes: a plurality of connecting windows, each connecting window being defined by a closing frame including a wider first portion and a narrower second portion, the first portion being connected via a flexible strut portion to an upper elongated strut joint of the frame, the upper elongated strut joint being a joint between two angled struts of two adjacent elongated units in the upper row unit; and an axially extending strut arranged between two adjacent elongated units, wherein the connecting window is configured to bend from an elongated configuration to a bent configuration where the connecting window overlaps with the axially extending strut via its flexible strut portion. The prosthetic heart valve also includes a leaflet assembly comprising a plurality of leaflets, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissure, wherein each commissure is arranged within a corresponding second portion of a corresponding commissural window.

[0018] In another representative embodiment, a method for assembling a prosthetic heart valve comprising an annular frame and leaflet assembly includes bending a ferrule window of the annular frame to a first bending orientation between a fully extended configuration and a fully bent configuration, wherein the ferrule 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 flexible strut portion to an upper elongated strut joint of the annular frame, the upper elongated strut joint being a joint between two angled struts of two adjacent elongated units arranged in the upper row of elongated units at the outflow end of the annular frame; and an axially extending strut arranged between the two adjacent elongated units, wherein in the fully extended configuration, the flexible strut portion is not bent and the ferrule window extends axially outward relative to the central longitudinal axis of the annular frame and away from the outflow end of the annular frame, while in the fully bent configuration, the ferrule window overlaps with the axially extending strut. The method further includes inserting a connector, at least partially pre-assembled to the outside of an annular frame, into a connector window, wherein the connector includes connector lugs on which pairs of adjacent leaflets of the leaflet assembly are fixed together. The method also includes bending the connector window to a fully bent configuration such that the connector window extends parallel to and is arranged radially inward of the axially extending strut, and fixing the connector window to the annular frame in its fully bent configuration.

[0019] In another representative embodiment, a method of assembling a prosthetic heart valve comprising an annular frame and leaflet assemblies includes inserting a commissure, at least partially pre-assembled to the outside of the annular frame, through an opening in a leaflet receiving window of a commissure support element into the leaflet receiving window, wherein the commissure includes commissure lugs of adjacent leaflets of the leaflet assembly fixed together, wherein the leaflet receiving window is formed by at least a portion of two axially extending members of the commissure support element that open at a first end and are connected at opposite second ends by a connecting member, and wherein the commissure support element includes a connecting portion that connects to the leaflet receiving window and is adapted to connect to portions of two adjacent units in an upper row of units forming the annular frame, the upper row of units being arranged at the outflow end of the annular frame and having a length elongated relative to units in the remaining rows of units of the annular frame in an axial direction relative to the central longitudinal axis of the annular frame. The method further includes attaching the connecting support element to the portion of the annular frame such that the leaflet receiving window and the connecting portion disposed therein are arranged in the lower portion of the upper row unit and an opening area not blocked by the leaflet is formed in the upper portion of the upper row unit.

[0020] In another representative embodiment, the prosthetic heart valve includes: an annular frame comprising a plurality of interconnected struts defining a multi-row unit disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end that extends axially relative to the units in the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame; a plurality of leaflets located within the frame, each leaflet including opposing merging lugs on opposite sides of the leaflet, each merging lug pairing with an adjacent merging lug of an adjacent leaflet to form a merging portion; and at least one merging portion support element comprising a connecting portion and two axially extending members radially offset from the connecting portion and laterally spaced apart from each other to form a leaflet receiving window configured to receive an opening of the merging portion, wherein the connecting portion is configured to connect to the upper edges of two adjacent units in the upper row unit, the upper edges being disposed at the outflow end of the frame, and wherein the leaflet receiving window is spaced axially from the upper edges.

[0021] In another representative embodiment, the prosthetic heart valve includes an annular frame comprising a plurality of interconnected struts defining multiple rows of units arranged between an outflow end and an inflow end of the frame and including an upper row of units arranged at the outflow end that extends axially relative to the units in the remaining rows of units in the multiple rows, the axial direction being relative to the central longitudinal axis of the frame. The struts defining the upper row of units include a plurality of axial struts, each axial strut forming a common axial side of two adjacent units in the upper row of units. A portion of the plurality of axial struts is a window axial strut, each window axial strut including a closed strut window positioned along the length of the window axial strut at a distance from its upper end. The prosthetic heart valve further includes: a plurality of leaflets located within a frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissure; and at least one commissural support element including a connecting portion and two axially extending members, the two axially extending members being radially offset from the connecting portion and laterally spaced apart from each other to form a leaflet receiving window configured to receive an opening of the commissure, wherein the connecting portion is configured to connect to a strut window.

[0022] In another representative embodiment, the prosthetic heart valve includes: an annular frame comprising a plurality of interconnected struts defining multiple rows of units arranged between an outflow and an inflow end of the frame and including an upper row of units arranged at the outflow end; and a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural portion. The struts defining the upper row of units further define commissural windows forming a plurality of openings between adjacent units in the upper row of units, each commissural window being configured to receive a commissural portion therein and formed by two axially extending window struts spaced apart from each other in a circumferential direction, wherein the commissural windows are axially offset toward the upstream / inflow end of the upper row of units.

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

[0024] Figure 1 A three-dimensional view of a prosthetic heart valve according to one embodiment is shown.

[0025] Figure 2 A perspective view of an exemplary frame of a prosthetic heart valve is shown.

[0026] Figure 3 The display shows the flat configuration. Figure 2 Side view of the frame.

[0027] Figure 4 Showing Figure 3 A detailed view of a portion of the frame, in which pairs of leaflets are arranged within the frame's window.

[0028] Figure 5 A detailed view of a portion of the frame of a prosthetic heart valve according to one embodiment is shown, the frame of which includes an open ferrule window.

[0029] Figure 6 A perspective view of an exemplary window fastener is shown, the window fastener being configured to be arranged in... Figure 5 The opening is located within a portion of the connecting window.

[0030] Figure 7 Showing Figure 6 A top view of the window fastener, which is arranged in... Figure 5 Inside the opening of the connecting window.

[0031] Figure 8A detailed view of a portion of the frame of a prosthetic heart valve according to another embodiment is shown, the frame of which includes an open ferrule window.

[0032] Figure 9 Showing Figure 8 A detailed view of the frame portion, wherein the joint is arranged within the opening of the joint window.

[0033] Figure 10 A detailed view of a portion of the frame of a prosthetic heart valve according to another embodiment is shown, the frame of which includes an open ferrule window.

[0034] Figure 11 Showing Figure 10 A detailed view of the frame portion thereof, wherein the connecting lug is arranged within an opening of the connecting window portion of the opening.

[0035] Figure 12 An exemplary leaflet including an axial extension is shown, the axial extension being configured to be arranged in... Figure 10 The opening is located within a portion of the connecting window.

[0036] Figure 13 Displayed in Figure 10 A cross-sectional top view of one embodiment of the connecting part within the opening of the connecting part window.

[0037] Figure 14 Displayed in Figure 10 A cross-sectional top view of another embodiment of the connecting part within the opening of the connecting part window.

[0038] Figure 15 A detailed view of a portion of the frame of a prosthetic heart valve according to one embodiment is shown, the frame of which includes a flexible ferrule window.

[0039] Figure 16 Showing Figure 15 A detailed view of the frame portion, wherein the connecting window is turned over the axially extending support of the frame and the connecting portion is arranged within the connecting window.

[0040] Figure 17 It is a flowchart of a method for assembling the syndesm within a flexible syndesm window of a prosthetic heart valve frame and fixing the flexible syndesm window containing the syndesm to the frame.

[0041] Figure 18An exemplary embodiment of a fusion support element is shown, which is configured to attach to the frame of a prosthetic heart valve and receive the fusion portion within a leaflet receiving window of the fusion support element.

[0042] Figure 19 A detailed view of a portion of the frame of a prosthetic heart valve is shown, in which Figure 18 The connecting support element is connected to the upper row of extension units of the frame.

[0043] Figure 20 Displayed in Figure 18 The connecting part within the supporting element and the connection to Figure 19 The supporting elements of the frame's joints.

[0044] Figure 21 Showing Figure 18 The connecting part support element, the connecting part support element being connected to Figure 19 The upper row of elongated units of the frame is located radially inside the axial struts of the frame, and the axial struts have a wider width than the other axial struts of the frame.

[0045] Figure 22 A detailed view of a portion of the frame of a prosthetic heart valve is shown, the frame of which includes an axial strut with a strut window configured to receive a fusion support element.

[0046] Figure 23 Showing Figure 22 A detailed view of the frame portion, wherein an exemplary joint support element is connected to a pillar window.

[0047] Figure 24 Showing Figure 22 A detailed view of the frame portion thereof, wherein an exemplary joint support element is connected to a pillar window and the joint is arranged within a leaf receiving window of the joint support element.

[0048] Figure 25 This is a side view of an embodiment of a delivery device configured to deliver a radially expandable prosthetic heart valve and implant it at the implantation site. Detailed Implementation

[0049] General considerations

[0050] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, systems, and apparatuses should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of various disclosed embodiments, individually and in various combinations and sub-combinations with each other. The disclosed methods, systems, and apparatuses are not limited to any particular aspect, feature, or combination thereof, nor are they required to address any one or more specific advantages or problems.

[0051] The features, integers, properties, compounds, chemical portions, or groups described in connection with a particular aspect, embodiment, or example of this disclosure should be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible with it. All functions disclosed in this specification (including any appended claims, abstract, and drawings) and / or all steps of any method or process so disclosed can be combined in any way, except that at least some of these features and / or steps are mutually exclusive combinations. This disclosure is not limited to the details of any of the foregoing embodiments. This disclosure extends to any novel one or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or to any novel one or any novel combination of steps in any method or process so disclosed.

[0052] While some operations in the disclosed methods are described in a specific sequential order for ease of presentation, it should be understood that this descriptive approach includes rearrangement unless the specific language used in the following description requires a particular order. For example, the sequentially described operations may be rearranged or performed concurrently in some cases. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods, systems, and apparatus can be used in conjunction with other systems, methods, and apparatuses.

[0053] As used herein, the terms “a,” “an,” and “at least one” cover one or more of the specified elements. That is, if two of the specified elements are present, then one of those elements is also present, and therefore there is “a” element. The terms “multiple” and “plural” mean two or more of the specified elements.

[0054] As used herein, the term “and / or” used between the last two elements in an element list refers to 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”.

[0055] As used in this article, the term “connection” generally means a physical link or connection, and does not exclude the existence of intermediate elements between the linked items in the absence of a specific opposite language.

[0056] Orientation and other relative references (e.g., inside, outside, upper, lower, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, terms such as “inner,” “outer,” “top,” “down,” “internal,” “external,” etc., may be used. Where applicable, such terms are used to provide a clear description in dealing with relative relationships, particularly with respect to the illustrated embodiments. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, simply by flipping the object over, the “upper” portion can become the “lower” portion. Nevertheless, it remains the same portion, and the object remains the same. As used herein, “and / or” means “and” or “or,” and “and” with “or.”

[0057] In the context of this application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, the lower end of the valve is its inflow end, and the upper end of the valve is its outflow end.

[0058] As used herein, with respect to prosthetic heart valves and delivery devices, "proximal" refers to the location, orientation, or portion of the component closer to the user and / or the object's external delivery device handle, while "distal" refers to the location, orientation, or portion of the component further away from the user and / or the delivery device handle and closer to the implantation site. Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, respectively. Furthermore, the term "radial" refers to a direction perpendicular to the axis and pointing along a radius originating from the center of the object (where the axis is centrally located, such as the longitudinal axis of a prosthetic valve).

[0059] Examples of the disclosed technology

[0060] This document describes examples of prosthetic heart valves and methods for assembling prosthetic heart valves comprising an annular frame and multiple leaflets. The prosthetic heart valve may include an annular frame and multiple leaflets attached to the frame via a commissure formed by connecting paired adjacent ends of the leaflets (e.g., commissure lugs). In some embodiments, the commissure may be formed at least partially on the outside of the annular frame.

[0061] In some embodiments, the annular frame of the prosthetic heart valve may include multiple rows of units formed by interconnected struts of the frame. These multiple rows of units may include an upper row of units (e.g., arranged at the outflow end of the frame). In some embodiments, the units in the upper row are elongated in the axial direction relative to the units in the remaining rows of units of the frame.

[0062] In some embodiments, a portion of the struts on the axial sides of two adjacent elongated units in the upper row of the annular frame can form a connecting window, which is adapted to receive the connecting portion and arrange the connecting portion in the lower region of the two adjacent elongated units (e.g., in a region further away from the outflow end of the frame). In some embodiments, the frame can be configured such that the connecting window is axially offset toward the inflow (e.g., upstream) end of the unit in the upper row.

[0063] In other embodiments, a portion of the strut on the axial side of two adjacent elongated units in the upper row of the annular frame may be adapted to receive a connecting support element, which is adapted to receive a connecting portion. Additionally, the portion of the strut and / or the connecting support element may be adapted to arrange the connecting portion in the lower region of the two adjacent elongated units.

[0064] In this manner, the commissure and its associated leaflets can be arranged in the lower region of the upper row unit (e.g., offset from the outflow end of the frame and toward the inflow end), thereby leaving a space for a relative opening in the upper region of the upper row unit near the outflow end of the frame. This space for a relative opening can provide increased blood flow through the valve and / or allow passage of a reentry device, as further described herein.

[0065] Figure 1 A prosthetic heart valve 10 according to one embodiment is shown. The illustrated prosthetic valve is suitable for implantation in a natural aortic valve annulus, but in other embodiments it may be suitable for implantation in other natural valve annulus of the heart (e.g., pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may also be suitable for implantation in other tubular organs or passageways within 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 perivalvular external sealing member or outer skirt 18. The prosthetic valve 10 may have an inflow end portion 15, a middle portion 17, and an outflow end portion 19.

[0066] The valve structure 14 may include three leaflets 40 that together form a leaflet structure, which may be arranged in a tricuspid valve arrangement folded, but in other embodiments more or fewer leaflets (e.g., one or more leaflets 40) may be used. The leaflets 40 may be fixed to each other on their adjacent sides to form a junction 22 of the leaflet structure 14. The lower edge of the valve structure 14 may have a wavy, curved, fan-shaped shape and may be fixed to the inner skirt 16 by sutures (not shown). In some embodiments, the leaflets 40 may be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118 (which is incorporated herein by reference).

[0067] The frame 12 may be formed with a plurality of circumferentially spaced slots, or adapted to mount the ferrule 22 of the valve structure 14 to the ferrule window 20 of the frame. The frame 12 may be made of any of a variety of suitable malleable expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi) such as nitinol). When constructed of a malleable expandable material, the frame 12 (and therefore the prosthetic valve 10) may be folded into a radially constricted configuration on a delivery catheter or delivery device, and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 12 (and therefore the prosthetic valve 10) may be folded into a radially constricted configuration and confined within the constricted configuration by insertion into a sheath of a delivery catheter or equivalent mechanism. Once in the body, the prosthetic valve can be advanced from the delivery sheath, allowing the prosthetic valve to expand to its functional size.

[0068] Suitable malleable expansion materials that can be used to form the frame 12 include, without limitation, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific embodiment, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy (e.g., The alloy (SPS Technologies, Jenkintown, Pennsylvania) is equivalent to UNS R30035 alloy (covered by ASTM F562-02). The alloy / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Further details regarding the prosthetic valve 10 and its various components are described in WIPO patent application publication number WO2018 / 222799 (which is incorporated herein by reference).

[0069] Figure 25 A delivery device 800 according to one embodiment is shown, which can be used for implanting an expandable prosthetic heart valve (e.g., Figure 1(The prosthetic heart valve 10 or any other prosthetic heart valve described herein). In some embodiments, the delivery device 800 is particularly adapted to introduce the prosthetic valve into the heart.

[0070] Figure 25 The delivery device 800 in the illustrated embodiment is a balloon catheter including a handle 802 and a steerable outer shaft 804 extending distally from the handle 802. The delivery device 800 may also include an intermediate shaft 806 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 802, the portion extending distally from the handle 802 also coaxially extending through the outer shaft 804. Additionally, the delivery device 800 may also include an inner shaft 808, which extends distally from the handle 802 coaxially through the intermediate shaft 806 and the outer shaft 804 and extends proximally from the handle 802 coaxially through the intermediate shaft 806.

[0071] 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 to facilitate delivery of the prosthetic valve and positioning at the implantation site in the subject.

[0072] The intermediate shaft 806 may include a proximal portion 810 extending proximally from the proximal end of the handle 802 to the adapter 812. A rotatable knob 814 may be mounted on the proximal portion 810 and may be configured to allow the intermediate shaft 806 to rotate about a central longitudinal axis 820 and relative to the outer shaft 804.

[0073] The adapter 812 may include a first port 838 and a second port 840, the first port 838 being configured to receive a guidewire passing through it, and the second port 840 being configured to receive fluid (e.g., an expansion fluid) from a fluid source. The second port 840 may be fluidly coupled to the interior of the intermediate shaft 806.

[0074] The intermediate shaft 806 may also include a distal 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 portion of the inner shaft 808 may extend distally beyond the distal portion of the intermediate shaft 806.

[0075] The balloon 818 can be attached to the distal portion of the intermediate shaft 806.

[0076] In some embodiments, the distal end of the balloon 818 may be coupled to the distal end of the delivery device 800, such as to the nasal cone 822 (e.g. Figure 25(as shown), or an alternative component (e.g., distal shoulder) coupled to the distal end of the delivery device 800. The intermediate portion of the balloon 818 may cover the valve mounting portion 824 of the distal portion of the delivery device 800, while the distal portion of the balloon 818 may cover the distal shoulder 826 of the delivery device 800. The valve mounting portion 824 and the intermediate portion of the balloon 818 may be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown... Figure 25 As illustrated, 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.

[0077] The balloon shoulder assembly, including the distal shoulder 826, is configured to maintain the prosthetic heart valve 850 (or other medical device) in a fixed position on the balloon 818 during delivery through the patient's vascular system.

[0078] The outer shaft 804 may include a distal tip portion 828 mounted on its distal end. When the prosthetic valve 850 is mounted on the valve mounting portion 824 in a radially compressed state (e.g.) Figure 25 (As shown) and during the delivery of the prosthetic valve to the target implantation site, the outer axis 804 and the intermediate axis 806 can be axially translated relative to each other to position the distal tip portion 828 proximally to the valve mounting portion 824. Thus, the distal tip portion 828 can be configured to resist axial proximal movement of the prosthetic valve 850 relative to the balloon 818 when the distal tip portion 828 is positioned proximally to the valve mounting portion 824.

[0079] An annular space may be defined between the outer surface of the inner shaft 808 and the inner surface of the intermediate shaft 806 and may be configured to receive fluid from a fluid source via a second port 840 of the adapter 812. The annular space may be fluidly coupled to a fluid passage formed between the outer surface of the distal portion of the inner shaft 808 and the inner surface of the balloon 818. Thus, fluid from the fluid source may flow from the annular space to the fluid passage to inflate the balloon 818 and radially expand and deploy the prosthetic valve 850.

[0080] The inner cavity of the inner shaft can be configured to receive a guidewire passing through it for navigating the distal portion of the delivery device 800 to the target implantation site.

[0081] Handle 802 may include an actuation mechanism configured to adjust the curvature of the distal portion of the delivery device 800. In an example embodiment, handle 802 may include, for example, an adjustment member, such as a rotatable knob 860, which is operatively coupled to the proximal portion of the draw wire. The draw wire may extend distally from handle 802 through outer shaft 804 and has a distal portion attached to outer shaft 804 at or near its distal end. Rotating knob 860 increases or decreases the tension in the draw wire, thereby adjusting the curvature of the distal portion of the delivery device 800. Further details regarding the actuation mechanism or flexure mechanism of the delivery device can be found in U.S. Patent No. 9,339,384 (which is incorporated herein by reference).

[0082] The handle 802 may also include an adjustment mechanism 861, which includes an adjustment member, such as the rotatable knob 862 shown, and an associated locking mechanism, which includes another adjustment member configured to rotate the knob 878. The adjustment mechanism 861 is configured to adjust the axial position of the intermediate shaft 806 relative to the outer shaft 804 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 800 can be found in U.S. Provisional Applications 63 / 069,567 and 63 / 138,890 (which are incorporated herein by reference).

[0083] Figures 2-3 The bare frame 50 of the prosthetic heart valve is shown, which in some embodiments may be Figure 1 The frame 12 of the prosthetic valve 10 is shown. The frame 50 has an inlet end 52, an outlet end 54, and a central longitudinal axis 56 extending from the inlet end 52 to the outlet end 54 (e.g., axially). The frame 50 may be constructed using the above references. Figure 1 Made of any material as described. (See above reference.) Figure 1 As described, the frame 50 may include a plurality of connecting windows (e.g., open windows) 58 spaced apart from each other in a circumferential direction (e.g., around the circumference of the frame 50), each adapted to receive a pair of connecting lugs of a pair of leaflets arranged as connecting parts.

[0084] like Figure 3As shown, frame 50 includes angled pillars 60 of a first lower row I arranged end-to-end and extending circumferentially at the inflow end of the frame; angled pillars 62 extending circumferentially in the second row II; angled pillars 64 extending circumferentially in the third row III; and angled pillars 66 extending circumferentially in the fourth row IV at the outflow end of frame 12. The angled pillars 66 of the fourth row IV are connected to the angled pillars 64 of the third row III via a plurality of axially extending window frame (or pillar) portions 68 (which define the connecting window 58) and a plurality of axially extending pillars 70. Each axial strut 70 and each frame portion 68 extends from a position defined by the convergence of the lower ends of the two angled struts 66 (also referred herein as the upper strut joint or upper extended strut joint) (e.g., the end disposed inside the outlet 54 and further away from the outlet 54) to another position defined by the convergence of the upper ends of the two angled struts 64 (also referred herein as the lower strut joint or lower extended strut joint) (e.g., the end disposed closer to the outlet 54).

[0085] As used herein with respect to the ends of pillars, units, and other frame components, "upper" and "lower" can be vertically arranged relative to the frame as shown. For example, an "upper" component can be arranged closer to the outlet end than the inflow end of the frame, while a "lower" component can be arranged closer to the inflow end than the outlet end of the frame. Thus, in some embodiments, as described herein, the "upper end" of a pillar or joint window frame portion may be referred to as the outlet-facing end relative to the inflow and outlet ends of the frame, while the "lower end" of a pillar or joint window frame portion may be referred to as the inflow-facing end. In yet other embodiments, an "upper" end, joint, or component may be referred to as a "proximal" end, joint, or component, while a "lower" end, joint, or component may be referred to as a "far" end, joint, or component.

[0086] Each connecting window frame portion 68 is fitted with a corresponding connecting part of the leaf structure (e.g., such as...). Figure 1 and Figure 4 As shown). Figure 3 As can be seen, each frame section 68 is fixed at its upper and lower ends to the adjacent row of struts to provide a robust configuration that enhances fatigue resistance under cyclic loading of the valve compared to known cantilevered struts, for supporting the commissure of the leaflet structure.

[0087] The pillars and frame portion of frame 50 together define a plurality of open units within the frame. At the inlet end 52 of frame 50, pillars 60 and 62 define a lower row of units defining opening 72. A second row of pillars 62 and a third row of pillars 64 define middle rows of units defining opening 74. A third row of pillars 64 and a fourth row of pillars 66, together with frame portion 68 and pillars 70, define an upper row of units defining opening 76. Opening 76 is relatively large (e.g., larger than openings 72 and 74) and may be referred to as elongated opening 76.

[0088] In some embodiments, as used herein, the support 66 may be referred to as the upper angled support 66 of the elongated unit in the upper row unit, and the support 64 may be referred to as the lower angled support 64 of the elongated unit in the upper row unit.

[0089] Although Figure 3 Three rows of units are shown, with the top row being elongated; however, in alternative embodiments, frame 50 may have a different number of rows of non-elongated units. For example, in an alternative embodiment, frame 50 may include an upper row of elongated units defining an opening 76, and a single row of units having smaller non-elongated openings (e.g., defining opening 74). In yet another embodiment, frame 50 may include an upper row of elongated units defining opening 76, and three additional rows of units having smaller non-elongated openings.

[0090] In some implementations, the frame may be a smaller diameter frame for smaller diameter prosthetic heart valves. For example, conventional transcatheter heart valves may have an expansion diameter in the range of 23-29 mm. For example, smaller diameter transcatheter heart valves may have a diameter of approximately 20 mm. In some implementations, smaller diameter valves may have a diameter of less than 22 mm. In other implementations, smaller diameter valves may have a diameter in the range of 19-21 mm. However, these smaller diameter valves may be used less frequently due to the inherently smaller unit size of these smaller diameter valves and the various challenges posed by the arrangement of the leaflets within the frame. As an example, the smaller unit size of a smaller diameter valve may reduce or interfere with blood flow into the coronary ostium after a valve-in-valve (e.g., a prosthetic valve-in-prosthetic) procedure. As another example, after valve implantation, the smaller unit size may at some later time prevent optional coronary re-entry devices from passing through it.

[0091] To at least partially address these issues, upper row units (e.g., arranged near the outflow end of the frame) are used. Figure 3 The unit with the limited opening of 76 can be elongated relative to other rows of units in the frame, such as... Figures 2-3 and Figure 4As shown (as further described below). However, the leaflet assembly of the prosthetic valve includes a commissure attached to the commissure window 58 (e.g., as shown below). Figure 1 (As shown), this may at least partially block the opening of the upper unit, thereby reducing blood flow and the pathway for coronary reentry into the device.

[0092] Therefore, it is desirable to have a joint attachment configuration that holds the leaflet of the prosthetic valve in a position within the frame that maintains a relative opening in the upper unit near the outflow end of the frame, a position sufficient to allow blood flow to the coronary ostium and the passage of the coronary reentry device after the prosthetic valve is implanted.

[0093] For example, such as Figure 4 As shown, the connecting part 80 can be arranged in the lower part of the connecting part window 58, and the connecting part 80 includes a pair of connecting lugs 82a and 82b of corresponding leaflets 84a and 84b. Specifically, Figure 4 A portion of frame 50 is shown (e.g.) Figure 3 A detailed view (shown as a whole) includes a connecting window 58 and a pair of connecting lugs 82a and 82b extending therethrough. As described above, it is desirable to hold the connecting portion 80 within the lower portion of the connecting window 58 such that the connecting portion 80 is arranged adjacent to the lower edge of the window frame portion 68 (e.g., towards the inflow or upstream end of the upper unit). As a result, the connecting portion 80 and the leaflets 84a and 84b are axially offset from the outflow end of the valve and held within the lower region 88 of the upper unit, thereby maintaining a relatively open space within the upper region 86 of the upper unit. This creates a more open unit region within the upper unit closer to the outflow end 54 of the frame 50.

[0094] Therefore, it is desirable to configure the frame of the prosthetic valve and / or the commissure support (or attachment) element that can be attached to the frame such that they hold the commissure and its corresponding leaflet within the lower region (or portion) of the upper elongation unit. Additionally, the frame and / or commissure support element can be configured such that the commissure can be pre-assembled to the outside of the frame and then inserted (e.g., slid) into the frame and / or commissure support element (e.g., from above or below – due to the commissure window in the frame and / or the commissure support element, which is at least partially open). This configuration and assembly method reduces the assembly time of the prosthetic valve and increases the overall ease of manufacturing the prosthetic valve.

[0095] Figure 5 , Figures 8-11 , Figures 13-16 as well as Figures 19-24Different embodiments of a prosthetic heart valve frame are shown, the frame having an elongation unit at the outflow end of the frame, wherein at least portions of a plurality of elongation struts forming the elongation unit are configured to receive a ferrule and / or a ferrule support element coupled to the ferrule. The portions of the plurality of elongation struts may be configured to hold the ferrule within a lower portion of the elongation unit disposed away from the outflow end of the frame, thereby maintaining the opening of the opposing upper portion of the elongation unit and preventing obstruction by the leaflets of the prosthetic heart valve. Additionally, the portions of the plurality of elongation struts may be configured to receive a ferrule support element or a pre-assembled ferrule.

[0096] Figure 5 , Figures 8-11 , Figures 13-16 and Figures 19-24 The prosthetic heart valve framework shown can be similar to Figures 2-3 The frame 50 shown, therefore, Figure 5 , Figures 8-11 , Figures 13-16 and Figures 19-24 Frame components that are identical to those in frame 50 are labeled as identical. For example, Figure 5 , Figures 8-11 , Figures 13-16 and Figures 19-24 The different frame implementations shown may have a connecting window frame portion and / or axial struts, which at least partially form the elongated units at the outlet end, modified from frame 50, while the rest of the frame remains similar to the rest of frame 50 (e.g., struts forming smaller lower row units). Therefore, even Figure 5 , Figures 8-11 , Figures 13-16 and Figures 19-24 It may only show a portion of the syndesm window frame or strut of the prosthetic heart valve frame, which includes a syndesm window adapted to receive a syndesm or syndesm support element, but the omitted frame portion may resemble... Figures 2-3 The corresponding part of frame 50.

[0097] Figure 5 A first embodiment of the frame 100 is shown, which has an extension unit at the outlet end 54 of the frame 100 and a connecting window 102 with a plurality of openings formed by window pillars 104a and 104b extending axially from the extension unit. Figure 5(Only one is shown in the image), each opening of the connecting window 102 is configured to receive the connecting portion within the lower region (or portion) of the opening of the connecting window 102. Each opening of the connecting window 102 is formed by a gap region between the axially extending window pillars of adjacent elongated units. Furthermore, each opening of the connecting window 102 includes a lower region 118 configured to receive the connecting portion's lug and an upper region 116 arranged near the outlet end 54 of the frame 100.

[0098] More specifically, such as Figure 5 As shown, the opening of the connecting window 102 is formed between a first axially extending window pillar 104a of a first elongating unit 106a and a second axially extending window pillar 104b of a second elongating unit 106b, with the first elongating unit 106a and the second elongating unit 106b arranged adjacent to each other in the circumferential direction within the frame 100. The first axially extending window pillar 104a and the second axially extending window pillar 104b are spaced apart from each other in the circumferential direction by a distance (e.g., a gap) 108. The distance 108 can be selected to receive the connecting lugs 82a and 82b of the connecting portion 110 therein (e.g., it can be the same as, slightly smaller than, or larger than, the width of the two connecting lugs).

[0099] like Figure 5 As shown, the opening of the ferrule window 102 is open at its upper (also referred to as proximal) end (e.g., the end closest to the outflow end 54 of the frame 100). As a result, during the assembly of the prosthetic heart valve, the ferrule 110, including the ferrule lugs 82a and 82b fixed together, can slide into the opening of the ferrule window 102 (e.g., in the gap 108 formed between the first axially extending window strut 104a and the second axially extending window strut 104b).

[0100] For example, a joint 110 can be formed on the outside of the frame 100 by connecting the connecting lugs (e.g., connecting lugs 82a and 82b) of two adjacent leaflets (e.g., leaflets 84a and 84b) to each other. In some embodiments, the connecting lugs of the joint 110 may be connected to each other via one or more stitches. In some embodiments, each connecting lug of the joint 110 may be folded away from the adjacent leaflet (e.g., at approximately 90 degrees), and a reinforcing member may be positioned between the folded (e.g., curved) angles of the connecting lugs. The reinforcing member may be secured to the connecting lug via one or more fasteners (e.g., stitches). In some embodiments, the reinforcing member may be referred to as a wedge member. The width of the reinforcing member (extending in the circumferential direction) may be large enough to prevent the connecting lug from being pulled back through the connecting window 102 of the opening after the joint 110 is inserted into the opening and the leaflet is arranged within the frame 100. It should be noted that in some embodiments, other connecting parts described herein can be formed in a manner similar to connecting part 110 as described above.

[0101] Each of the axially extending window pillars 104a and 104b includes a corresponding lower (or distal) window pillar portion 112a and 112b and a corresponding upper (or proximal) window pillar portion 114a and 114b. Therefore, the lower region 118 of the joined window is defined between the lower window pillar portions 114a and 114b, while the upper region 116 of the joined window is defined between the upper window pillar portions 114a and 114b.

[0102] Additionally, the connecting window 102 is closed at its lower (e.g., distal) end. For example, the connecting window 102 may be closed at its lower end by a transverse window pillar portion 113 that connects the lower ends of the lower window pillar portions 112a and 112b of the axially extending window pillars 104a and 104b together.

[0103] like Figure 5 As shown, the horizontal window support portion 113 is also connected to the angled support 64, which defines a portion of the units in the second row of units arranged adjacent to the upper row of elongated units.

[0104] In this way, the lower region 118 of the connecting window is closed at its lower end, and the lower edges of the connecting lugs 82a and 82b can be positioned against the transverse window support portion 113.

[0105] like Figure 5As shown, the height 120 of each connecting lug 82a and 82b, that is, the height 120 extending between the edge of the fan-shaped line 122 and the upper edge 124 of each connecting lug, can be closely matched (e.g., the same or slightly less) with the height of the lower region 118 of the connecting window (which is the same as the length 128 of the lower window support portions 112a and 112b, as described below).

[0106] Because the height (e.g., length 128) of the lower region 118 of the merging window is less than the total height of the opening of the merging window 102, the leaflets 84a and 84b of the merging lugs 82a and 82b arranged therein do not obstruct the upper portion (e.g., region) 142 of the opening 76 of the elongation units 106a and 106b. As a result, the opening 76 has a sufficiently large opening area to ensure adequate blood flow to the coronary artery ostium after implantation of the prosthetic heart valve and to allow re-entry devices to pass through it.

[0107] In some embodiments, the length 128 of the lower window pillar portions 112a and 112b may be longer than the length 130 of the upper window pillar portions 114a and 114b. In some embodiments, the length 128 of the lower window pillar portions 112a and 112b is in the range of 4-6 mm, while the length 130 of the upper window pillar portions 114a and 114b is in the range of 1-2 mm. In some embodiments, the length 128 of the lower window pillar portions 112a and 112b is in the range of 4.4-5.5 mm, while the length 130 of the upper window pillar portions 114a and 114b is in the range of 1.25-1.75 mm. In some embodiments, the length 128 of the lower window pillar portions 112a and 112b is approximately 5 mm, while the length 130 of the upper window pillar portions 114a and 114b is approximately 1.5 mm.

[0108] In some embodiments, the upper window pillar portions 114a and 114b each include a recessed portion 132, which creates a narrowed portion of the corresponding upper window pillar portion. The length of each recessed portion 132 may be shorter than the length 130 of the corresponding upper window pillar portion 114a or 114b. See the following reference... Figure 6 and Figure 7 To further explain, the recessed portion 132 of the upper window support portions 114a and 114b may be shaped to receive window fasteners (e.g., spacers).

[0109] In some embodiments, the length 128 of the lower window support portions 112a and 112b is selected to closely match the height 120 of the connecting lugs 82a and 82b.

[0110] In some embodiments, the length 130 of the upper window support portions 114a and 114b is selected such that after the joint portion 80 is assembled into the corresponding opening of the joint window 102—which is large enough to ensure adequate blood flow to the coronary artery orifice and to allow re-entry devices to pass through therein—the unit region of the opening within the elongated units 106a and 106b remains.

[0111] After implantation of a prosthetic heart valve, during valve operation, the leaflets can move from an open state during systole to a closed state during diastole. This constant cyclic movement of the leaflets exerts a lateral force (e.g., circumferential) on the axially extending window struts 104a and 104b, causing them to extend away from each other. Therefore, in some embodiments, a joint window fastener can be inserted between the axially extending window struts of each open joint window (e.g., window 102). The joint window fastener can be configured to secure the axially extending window struts of the open joint windows together to prevent lateral movement of the axially extending window struts relative to each other. In some embodiments, the joint window fastener may be referred to as a spacer because it is adapted to maintain a relatively constant distance between the axially extending window struts of the open joint windows in the circumferential (e.g., lateral) direction.

[0112] Figure 6 and Figure 7 An exemplary embodiment of this connecting window fastener 150 is shown. Specifically, Figure 6 A 3D view of window fastener 150 is shown, while Figure 7 A top view shows the window fastener 150 connected within the opening of the connecting window 102.

[0113] like Figure 6 and Figure 7 As shown, the window fastener 150 has an H (or I in some embodiments) shape. The window fastener 150 includes a central portion 152 and two opposing ends 154 and 156, the central portion 152 extending between the two ends 154 and 156. The two ends 154 and 156 have a width 158 that is wider than the width 160 of the central portion 152.

[0114] Figure 7A top view of a window fastener 150 inserted into the upper region 116 of the connecting window 102 is shown. Specifically, in some embodiments, the middle portion 152 may slide downward into the upper region 116 from the open end of the connecting window 102 (near the upper region 116). Thus, the middle portion 152 is arranged between the upper window support portions 114a and 114b, while the ends 154 and 156 are respectively positioned radially outward and radially inward of the frame 100 (e.g., the supports of the frame). As used herein, the radial direction is relative to the central longitudinal axis of the annular frame 100. In this way, the first end 154 extends circumferentially along and between the radially outward side surfaces of the upper window support portions 114a and 114b, while the second end 156 extends circumferentially along and between the radially inward side surfaces of the upper window support portions 114a and 114b.

[0115] like Figure 5 As shown and described above, in some embodiments, the upper window support portions 114a and 114b may each include a recessed portion 132 configured to receive the middle portion 152 of the window fastener 150.

[0116] Therefore, the window fastener 150 can slide into the window 102 from above (e.g., the outflow end of the frame), slightly extending the upper window pillar portions 114a and 114b away from each other (e.g., pushing) during the initial stage of insertion, until the middle portion 152 snaps into place within the recessed portion 132 of the upper window pillar portions 114a and 114b.

[0117] In some embodiments, the width 160 of the middle portion 152 may be approximately the same as the resting distance 134 (e.g., not under tension or load) between the two upper window pillar portions 114a and 114b of the window 102, with the portion 132 recessed in one area.

[0118] like Figure 6 As shown, in some embodiments, the lateral edges 162 of the two ends 154 and 156 include a plurality of indentations (e.g., recesses) 164 configured to receive and support fasteners (e.g., stitching) surrounding and extending along the lateral edges 162. For example, after the window fastener 150 is positioned in place within the upper region 116 of the window 102, the stitching 166 may wrap around the ends 154 and 156, thereby pressing the upper window pillar portions 114a and 114b firmly against the window fastener 150 for secure fixation.

[0119] In this way, the window fastener 150 can maintain a relatively constant distance between the axially extending window struts 104a and 104b throughout the operation of the prosthetic heart valve. As a result, compression that would otherwise be applied to the connecting lugs arranged within the window 102 can be reduced or eliminated.

[0120] The above is for reference only. Figure 5 The described frame 100 provides a fusion window with a fusion receiving portion (e.g., lower region 118), the fusion receiving portion being configured to hold the fusion within a lower portion 140 of an elongation unit (e.g., elongation units 106a and 106b), the lower portion 140 being disposed away from the outflow end 54 of the frame 200. As a result, the opposing upper portion 142 of the elongation unit remains open and is not obstructed by the leaflets of the prosthetic heart valve (e.g., Figure 5 (As shown).

[0121] In another implementation, such as Figure 8 and Figure 9 As shown, the frame 200—having an elongation unit at the outlet end 54 of the frame 200—may have a connecting window 202 with a plurality of openings between parallel axially extending window pillars defined in the axially extending pillars of the elongation unit. Figure 8 and Figure 9 (Only one is shown in the image), axially extending window pillars extend from the upper axial pillar portion of the axially extending pillar. Each connecting window 202 may have an opening at its lower end and is arranged within the lower portions of two adjacent elongating units. For example, the axially extending window pillar may include a lower (e.g., distal) clamping portion defining a bottom opening therebetween through which the connecting portion slides into the connecting window 202 and is configured to clamp together to hold the connecting portion therein. In this way, the connecting window 202 configured to receive the connecting portion therein (e.g., Figure 9 The device (as shown) is positioned at a lower position within the elongation unit (e.g., away from the outflow end), thereby providing an opening area for blood flow and device access in the upper portion of the elongation unit.

[0122] More specifically, such as Figure 8 and Figure 9 As shown, an exemplary connecting window 202 is formed and defined between a first axially extending window pillar 204a and a second axially extending window pillar 204b. Figure 8As shown, the length 205 of the axially extending window pillars 204a and 204b is shorter than the length 207 of the axial pillar 70 of the elongation units 206a and 206b of the frame 200 (the axial pillar 70 does not include the connecting window). The axially extending window pillars 204a and 204b are integrally formed with the frame 200, each extending from the upper (e.g., proximal) axial pillar 208. The axially extending window pillars 204a and 204b, together with the upper axial pillar 208, can form an axially extending frame portion defining the axial side of each of the adjacent elongation units 206a and 206b.

[0123] In some embodiments, the thickness or width of the upper axial strut 208—defined in the circumferential direction and perpendicular to the central longitudinal axis 7 of the frame—may be the same as the thickness or width of the axially extending window struts 204a and 204b and / or other struts of the frame (e.g., angled struts 66).

[0124] In some embodiments, the thickness or width of the upper axial strut 208 may be greater than (e.g., thicker than) the thickness or width of the axially extending window struts 204a and 204b and / or other struts of the frame (e.g., angled struts 66).

[0125] In some embodiments, the upper axial support 208 may include other geometric features, such as one or more holes or notches along its length.

[0126] An upper axial strut 208 is arranged between the upper elongated strut joint 210 (e.g., the joint between the two angled struts 66 and the upper axial strut 208) and the upper edge 212 of the connecting window 202. The upper edge 212 is arranged substantially perpendicular to the upper axial strut 208 and laterally (e.g., circumferentially) offset the axially extending window struts 204a and 204b from each other. In other words, the upper edge 212 extends in a circumferential (or lateral) direction between the upper ends of each of the axially extending window struts 204a and 204b.

[0127] like Figure 8 As shown, the lower part of the extended support joint is replaced with the lower end of the opening of the connecting window 202.

[0128] For example, in some embodiments, each axially extending window pillar 204a and 204b includes lower clamping portions 214a and 214b, respectively, formed by a curved (e.g., angled) portion of the lower part of the corresponding axially extending window pillar 204a and 204b. Figure 8 and Figure 9 As shown, the curved portions of the lower clamping parts 214a and 214b are angled toward each other. Therefore, as Figure 8 and Figure 9As shown, the lower clamping portions 214a and 214b together form a neck region at the lower end of the connecting window 202 of the opening.

[0129] like Figure 9 As shown, the connecting lugs 82a and 82b of the connecting portion 216 can extend through the opening connecting window 202 to form a connecting assembly (e.g., a connecting portion assembled to the frame 200). For example, in some embodiments, the connecting lugs 82a and 82b of the leaflets 84a and 84b can be inserted into the connecting window 202 through the opening 218 defined between the lower clamping portions 214a and 214b.

[0130] In some embodiments, the axially extending window struts 204a and 204b and their respective lower clamping portions 214a and 214b may laterally flex or elastically bend (e.g., laterally outward and away from each other) during leaflet insertion.

[0131] In some embodiments, after the connecting lugs are positioned within the connecting window 202, the stitching 220 may be wrapped or encircled around the lower clamping portions 214a and 214b (e.g., wrapped or encircled around the outer bend of each of the lower clamping portions) to clamp the lower ends of the axially extending window pillars 204a and 204b together and prevent the connecting lugs 82a and 82b from axially sliding out of the connecting window 202. In alternative embodiments, optional fasteners or clamping devices (e.g., straps, ropes, ties, or the like) may be used to clamp the lower clamping portions 214a and 214b together.

[0132] In some embodiments, the lower clamping portions 214a and 214b may each include an angled lower portion and a relatively straight horizontal upper portion. The angled portions facilitate the sliding of the connecting lugs 82a and 82b upward (towards the outlet end 54) into the connecting window 202 from the bottom opening. The horizontal portion can serve as a support for the lower (e.g., bottom) base of the connecting lugs 82a and 82b held within the connecting window 202.

[0133] In an alternative embodiment, the lower portions of the lower clamping portions 214a and 214b may not be angled, but may instead be arranged relatively straight and perpendicular to the upper portions of the horizontal.

[0134] The upper edge 212 may be configured to reduce or prevent axial displacement of the coupling 216 upward toward the outlet end 54 in the axial direction. In some embodiments, a wedge member (not shown) may be inserted between the coupling 216 (e.g., the upper edge of the coupling lug) and the upper edge 212 to further reduce or prevent undesirable axial movement of the coupling 216 within the coupling window 202. The wedge member may be a fabric or polymer material, the thickness of which is chosen to be large enough to be positioned between the upper edge 212 and the upper edges of the coupling lugs 82a and 82b and to firmly abut against the upper edge 212 and the upper edges of the coupling lugs 82a and 82b.

[0135] In this way, Figure 8 and Figure 9 The opening (e.g., one end is an open end) window 202 of the frame 200 provides a way to insert and connect the connecting portion of the leaflet assembly to the frame having the elongated upper unit, thereby increasing the ease of manufacturing the prosthetic heart valve. Furthermore, by having the opening window 202 have a lower clamping portion that can be clamped together to secure the connecting portion within the respective window 202, the connecting portion can always be firmly held within its respective window 202—including during the transition between the folded and expanded states of the prosthetic heart valve frame, and during diastole (during the valve's operation in vivo).

[0136] Furthermore, in some embodiments, 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, can be selected such that the leaflet remains within the lower portion 240 of the elongation unit, while the upper portion 242 of the elongation unit remains unobstructed by the leaflet. In this way, the merging window 202 and thus the leaflet are axially biased toward the inflow end (which may also be referred to as the upstream end) of the upper row of units (e.g., units 206a and 206b). As a result, adequate blood flow through the upper portion 242 of the elongation unit and / or entry via the re-entry device is possible during valve operation.

[0137] For example, in some embodiments, the length 252 of the upper axial support 208 may be selected such that the outflow end 54 (e.g., the apex or outflow portion of the support 66 at the outflow end 54) and the leaflets 84a and 84b are joined at the junction (or at the axial position of the upper edge 212, such as...). Figure 9The axial distance 250 between the outflow edges (shown by the dashed line in the diagram) is within a selected range. In some embodiments, the selected range of the axial distance 250 is in the range of 2-6 mm, 2-4 mm, or 2-3 mm. In some embodiments, the selected range of the axial distance 250 is in the range of 20-50%, 25-45%, or 30-40% of the total axial distance (or height) of the elongation units 206a and 206b. In some embodiments, the length 252 of the upper axial support 208 may be in the range of 0.75-2.5 mm, 1-2 mm, or approximately 1.5 mm. As a result, the upper portion 242 of the elongation unit can be sized to provide sufficient blood flow and / or entry via a re-entry device.

[0138] In some embodiments, the outflow edges of leaflets 84a and 84b away from the commissure (and the commissure lugs 84a and 84b, toward the center of the valve (towards the central longitudinal axis of the frame)) can be higher (closer to the outflow end portion 54) or lower than the outflow edges of leaflets 84a and 84b at the commissure lugs 84a and 84b.

[0139] In some embodiments, the outflow edges of leaflets 84a and 84b away from the commissure (and the commissure lugs 84a and 84b, toward the center of the valve (towards the central longitudinal axis of the frame)) may also be biased axially at the outflow end 54 of the frame 200 by a distance 250.

[0140] In yet another implementation, such as Figure 10 , Figure 11 , Figure 13 and Figure 14 As shown, the frame 300—with an elongation unit at the outlet end 54 of the frame 300—may have a plurality of openings in the connecting window 302 (in Figure 10 , Figure 11 , Figure 13 and Figure 14 Only one is shown in the image), which is divided into two open window portions formed between an axial strut (e.g., an axially extending strut, similar to axially extending strut 70) and two axial strut arms arranged on either side of the axial strut. In some embodiments, the axial strut and each of the two axial strut arms may be referred to as an axially extending window strut (e.g., because they form the two open window portions of the connecting portion window 302). The two open window portions are separated from each other via the axial strut and are each configured to receive different connecting lugs of the connecting portion therein.

[0141] More specifically, such as Figure 10 and Figure 11As shown, each opening of the connecting window 302 may include a window portion 304a of a first opening and a window portion 304b of a second opening. The window portion 304a of the first opening is formed between (and defined by) the axial strut 316 and the first axial strut arm 308a, while the window portion 304b of the second opening is formed between (and defined by) the axial strut 316 and the second axial strut arm 308b.

[0142] The first axial strut arm 308a and the second axial strut arm 308b are integrally formed with the frame 300, extending parallel to the axial strut 316 from the lower elongated strut joint 310 of the frame 300 toward the outlet end 54 of the frame 300. The lower elongated strut joint 310 may be the joint between two angled struts 64 of two adjacent elongated units 306a and 306b. Furthermore, the axial strut 316 extends between the lower elongated strut joint 310 and the upper elongated strut joint 311. The upper elongated strut joint 311 may be the joint between two angled struts 66 of two adjacent elongated units 306a and 306b.

[0143] Each of the first axial strut arm 308a and the second axial strut arm 308b is laterally offset from the axial strut 316 (in opposite directions). In some embodiments, the lateral direction may also be referred to as the circumferential direction (because the frame 300 is annular).

[0144] In some embodiments, each of the first axial strut arm 308a and the second axial strut arm 308b may respectively include lateral portions 312a and 312b extending between the lower elongated strut joint 310 and the respective axial portions 314a and 314b of the first axial strut arm 308a and the second axial strut arm 308b. The lateral portions 312a and 312b may be arranged substantially perpendicular to the axial portions 314a and 314b.

[0145] The upper end of each of the first axial strut arm 308a and the second axial strut arm 308b, arranged near the outlet end 54 of the frame 300, may be free (e.g., not connected to other struts or portions of the frame 300). As a result, the first axial strut arm 308a and the second axial strut arm 308b may be individually bent or displaced away from the axial strut 316 in the lateral and / or radial directions, and then return to their axial orientation (e.g., generally parallel and radially aligned with the axial strut 316) when the bending or displacement force is no longer applied. As further explained below, the upper end of each of the first axial strut arm 308a and the second axial strut arm 308b may include corresponding upper clamping portions 318a and 318b.

[0146] like Figure 11 , Figure 13 and Figure 14 As shown, the connecting lugs 82a and 82b of the adjacent leaflets 84a and 84b can extend through the window portions 304a and 304b of the opening corresponding to the opening of the connecting window 302 to form the connecting portion 320. Figure 13 and Figure 14 The complete connecting part 320 is shown.

[0147] In some embodiments, the rest (e.g., unbent or undeflected) width 362 of the opening windows 304a and 304b can be selected based on the thickness of the connecting lugs 82a and 82b (e.g., such that the window portion of each opening is slightly narrower than the thickness of the connecting lug or the same width twice the thickness of the connecting lug).

[0148] For example, the connecting lugs 82a and 82b of leaflets 84a and 84b may extend through the window portions 304a and 304b of the opening, for example, by flexing or bending the axial strut arms 308a and 308b laterally outward (away from the axial strut 316) and / or radially inward (towards the central longitudinal axis of the frame 300). This facilitates the process of inserting the connecting lugs into the window portions 304a and 304b of the opening.

[0149] like Figure 11 , Figure 13 and Figure 14 As shown, the second connecting lug 82b extends radially outward from the main body of the leaflet 84b toward the frame 300 and through the window portion 304b of the second opening. The second connecting lug 82b can then be folded in half (e.g., folded from its first lug portion 322b) to form a second lug portion 324b, which extends radially inward through the window portion 304b of the same second opening. The second lug portion 324b can be folded laterally outward from the axial support 316 and over the corresponding second axial support arm 308b to form a third lug portion 326b.

[0150] like Figure 11 and Figure 13 As shown, in some embodiments, the third lug portion 326b may be disposed radially inward of the frame 300 (e.g., on the side facing radially inward relative to the central longitudinal axis of the frame). Similarly, as Figure 13As shown, the first connecting lug 82a extends radially outward from the body of the leaflet 84a toward the frame 300 and through the window portion 304a of the first opening. The first connecting lug 82a can then be folded in half (e.g., folded from its first lug portion 322a) to form a second lug portion 324a, which extends radially inward through the window portion 304a of the same first opening. The second lug portion 324a can be folded laterally outward from the axial support 316 and over the corresponding first axial support arm 308a to form a third lug portion 326a. It should be noted that, for the sake of illustration, Figure 11 Only the second connecting lug 82b is shown, but the first connecting lug 82a can be as described above and in Figure 13 Fold as shown in the image.

[0151] In the alternative implementation methods, such as Figure 14 As shown, the third lug portions 326a and 326b can be further folded over the lateral outward side of the corresponding axial strut arms 308a and 308b, thereby extending radially outward toward the radial outward side of the frame 300.

[0152] As described above, in some embodiments, each of the first axial strut arm 308a and the second axial strut arm 308b includes corresponding upper clamping portions 318a and 318b. For example, in some embodiments, such as Figure 10 and Figure 11 As shown, 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 outlet end 54 of the frame 300, and then bends laterally outward away from the axial support 316. As a result, a 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 outlet end 54 of the frame 300, and then bends laterally outward away from the axial support 316. As a result, a second recessed portion 340b is formed in the second upper clamping portion 318b. The first recessed portion 340a and the second recessed portion 340b of the upper clamping portions 318a and 318b together form a neck region at the upper (e.g., near) end of the outlet end 54 of the frame 300 adjacent to the connecting window 302.

[0153] In some embodiments, after the connecting lugs have extended through the window portions 304a and 304b of the openings, respectively, fasteners (e.g., stitching, tape, cord, or the like) may be wrapped around or surrounded the first recess 340a and the second recess 340b of the upper clamping portions 318a and 318b. As a result, the upper ends of the first axial support arm 308a and the second axial support arm 308b are clamped together and held to the axial support 316, thereby preventing the connecting lugs from axially sliding out of the window portions 304a and 304b of the openings.

[0154] In some embodiments, the distance (e.g., axial length) 360 between the lower elongated strut 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 lugs 82a and 82b.

[0155] In some implementations, such as Figure 12 As shown, leaflet 84b (and similarly, leaflet 84a) may include an axially extending portion 342, which is formed as a protrusion extending axially in the proximal (upper) direction at the transition region between leaflet 84b and connecting lug 82b. Figure 11 As shown, the axial extension 342 is aligned with the upper clamping portion 318b, such that the axial extension 342 is positioned laterally between the upper clamping portion 318b and the axial support 316. Although in Figure 12 Only the second leaflet 84b is shown, but the first leaflet 84a may also include an axial extension 342, which is arranged between the upper clamping portion 318a and the axial support 316 when inserted into the window 304a of the first opening.

[0156] In this embodiment, when sutures or other fasteners are wrapped around and tightened around the upper clamping portions 318a and 318b, the axial extensions 342 of leaflets 84a and 84b are clamped and held between the axial strut 316 and the corresponding upper clamping portions 318a and 318b. Therefore, the axial extensions 342 can be used to relieve stress on leaflets 84a and 84b during the transition between systole and diastole (during the operation of the prosthetic heart valve in vivo).

[0157] Figure 13 and Figure 14 Cross-sectional top views of two embodiments of the coupling 320 arranged within the coupling window 302 formed by the frame 300 are shown. In some embodiments, such as Figure 13 and Figure 14As shown, the first lug portions 322a and 322b of the leaflet can be folded over the corresponding reinforcing members 344a and 344b to form second lug portions 324a and 324b, respectively, extending from them toward the window portions 304a and 304b of the corresponding openings. In some embodiments, the reinforcing members 344a and 344b may be referred to as wedge-shaped members.

[0158] In some implementations, such as Figure 13 As shown, seams 346a and 346b can extend from the radially inward-facing side of frame 300 to the radially outward-facing side of frame, laterally outside the corresponding axial support arms 308a and 308b. For example, as Figure 13 As shown, each of the sutures 346a and 346b extends through three layers of the corresponding connecting lugs 82a and 82b, including corresponding first lug portions 322a and 322b, second lug portions 324a and 324b, and third lug portions 326a and 326b. In some embodiments, the sutures 346a and 346b may further extend through corresponding reinforcing members 344a and 344b disposed between the first lug portions and the second lug portions.

[0159] In some embodiments, fabric strips 348a and 348b may be disposed between the second lug portions 324a and 324b, the third lug portions 326a and 326b, and the axial support arms 308a and 308b, respectively. Therefore, fabric strips 348a and 348b can reduce wear on the connecting lugs 82a and 82b abutting against the axial support arms 308a and 308b. In some embodiments, stitches 346a and 346b may extend through the flaps or ends of the fabric strips 348a and 348b, respectively.

[0160] In some embodiments, fabric strips (such as fabric strips 348a and 348b) may be further provided at the joint lugs 82a and 82b and the axial support 316 ( Figure 13 (Not shown in the text)

[0161] In the alternative implementation methods, such as Figure 14 As shown, the third lug portions 326a and 326b are further folded over the laterally outward side of the corresponding axial strut arms 308a and 308b, thereby extending radially outward to the radially outward side of the frame 300 (and in some embodiments, extending radially outward to the frame 300). In these embodiments, a single stitch 350 may be located on the outer side of the frame 300 in the lateral direction (with...). Figure 13 (The radial directions shown are opposite) extend through all three layers of both the connecting lugs 82a and 82b (e.g., through a total of six leaflet lug layers).

[0162] In some embodiments, the stitch 350 may further extend through the reinforcing members 344a and 344b.

[0163] In some embodiments, the connecting lugs 82a and 82b can be folded over the reinforcing members 344a and 344b to form partially pre-assembled parts, thereby simplifying their insertion and attachment to the connecting window of the frame 300 disclosed above. For example, by folding and securing the connecting lugs, as referenced above... Figure 11 , Figure 13 and / or Figure 14 As can be explained, the connecting portion 320 can be assembled to the outside of the frame 300, and then the assembled connecting portion 320 can be inserted (e.g., slid) into the connecting portion window 302 (e.g., at the clamping portions 318a and 318b) through the opening at the upper end of the connecting portion window 302 formed by the free ends of the axial strut arms 308a and 308b. Specifically, the assembled connecting portion 320 can slide into the connecting portion window from above (e.g., the first folded connecting portion lug 82b enters the first opening window portion 304a through the opening between the axial strut 316 and the upper clamping portion 318a, and the second folded connecting portion lug 82b enters the second opening window portion 304b through the opening between the axial strut 316 and the upper clamping portion 318b). In this way, the assembly of the leaflet into the prosthetic heart valve can be simplified and made easier, thereby saving manufacturing time and labor.

[0164] In another implementation, such as Figure 15 and Figure 16 As shown, the frame 400—which has an elongation unit at its outlet end 54—may have a plurality of connecting windows 402 integral with the rest of the frame. Figure 15 and Figure 16 (Only one is shown in the image). Each connecting window 402 may extend from the upper edge 436 of the frame 400 (e.g., at the outlet end) and is configured to bend from the extended configuration to a curved configuration in which the connecting window 402 overlaps with the axially extending strut of the upper unit of the frame 400. The connecting window 402 may be a closed window formed by a strut frame 404, which includes a wider first portion 406 connected to the outlet end 54 of the frame 400 via a flexible strut portion 410 and a narrower second portion 408 configured to hold the connecting portion of the leaflet assembly therein. The flexible strut portion 410 may be configured to bend manually and maintain its curved shape (e.g., plastic deformation).

[0165] More specifically, such as Figure 15 and Figure 16 As shown, the frame 400 of the prosthetic heart valve may include an upper row of elongated units (similar to...) Figure 2and Figure 3 (Frame 50 shown). Figure 15 and Figure 16 This is a detailed view of a portion of frame 400, which includes two adjacent elongated units in the upper row of units, including a first elongated unit 412a and a second elongated unit 412b. The first elongated unit 412a and the second elongated unit 412b share an upper elongated strut joint 414 (e.g., Figure 15 (as shown) and the lower support joint 428 ( Figure 16 The axial struts 70 extending between the two angled struts 66 (e.g., arranged inside the outlet end 54 and furthest from the outlet end 54) have an upper extended strut joint 414 which is the joint between the lower ends of the two angled struts 66 (e.g., arranged inside the outlet end 54 and furthest from the outlet end 54) and a lower strut joint 428 which is the joint between the upper ends of the two angled struts 64 (e.g., arranged closer to the outlet end 54).

[0166] As described above, the frame 400 may include a plurality of integrally formed connecting windows spaced apart circumferentially around the frame 400. Figure 15 and Figure 16 Only one connecting window 402 is shown in the image. Each connecting window 402 may extend from the upper (e.g., proximal) edge 436 of the frame (e.g., the edge closest to the outlet end 54 and including the angled strut 66) and is adapted to bend over the axial struts (e.g., axial strut 70) of the upper unit.

[0167] like Figure 15 As shown, the connecting window 402 is formed as a closed window (e.g., without openings around its perimeter) and is surrounded by a support frame 404. The support frame 404 may include a plurality of connected support portions that are continuous with each other and form a wider first portion 406 and a narrower second portion 408 of the support frame 404. The second portion 408 is directly connected to the upper edge 436 of the frame 400 via a flexible support portion 410 at one of the upper extended support joints 414.

[0168] In some embodiments, the frame 404 of the connecting window 402 is formed by a known manufacturing method such as laser cutting.

[0169] The flexible strut portion (also referred to as the flexible strut) 410 may include an axial strut configured to bend (e.g., arranged parallel to the central longitudinal axis of the frame 400). In some embodiments, the flexible strut portion 410 is flexible and malleably deformable to allow the connecting window 402 to extend from an upwardly extending configuration (also referred to as a fully extended configuration, such as...). Figure 15 (as shown) transforms into a completely bent or flipped configuration (such as) Figure 16(As shown). Therefore, in some embodiments, the flexible support portion 410 may include a malleable material such as malleable metal or plastic.

[0170] In this way, the flexible support portion 410 can be configured to allow the connecting window 402 to be bent via manual force around the upper elongated support joint 414, and to maintain the bent orientation when the manual force (exceeding a set threshold) is no longer applied to the connecting window 402. As a result, spontaneous or undesirable displacement of the connecting window 402 from the selected orientation can be avoided.

[0171] like Figure 15 As shown, the first portion 406 has a first length 416 (along the axial direction) and a first width 418 (along the transverse or circumferential direction), while 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 can be selected to accommodate the connecting lugs of the connecting portion and to arrange the leaflets within the lower portion of the upper unit, as further explained below.

[0172] Figure 17 A method 500 is shown for assembling the joint within the joint window 402 and fixing the joint window containing the joint to the frame 400. Figure 16 The image shows an example of a joint 424 assembled within the joint window 402 and fixed to the frame 400. The joint 424 may include joint lugs 82a and 82b, respectively, of adjacent leaflets 84a and 84b, as shown. Figure 16 As shown.

[0173] Method 500 begins at 502, bending the connecting window 402 at least partially to its fully extended initial orientation (e.g., as shown in the image). Figure 15 (as shown) and a fully bent (e.g., flipped) orientation (such as) Figure 16 The selected orientation is between (shown). A fully extended orientation may be one in which the flexible strut portion 410 is not bent and extends substantially axially outward and away from the upper extended strut joint 414. In some embodiments, the method at 502 may include bending the joint window 402 by 90°–135° relative to the fully extended orientation. In other embodiments, the method at 502 may include bending the joint window 402 by 80°–160° relative to the fully extended orientation. In yet another embodiment, the method at 500 may include bending the joint window 402 by 75°–140° relative to the fully extended orientation.

[0174] Method 500 continues to 504 to insert the pre-assembled syndesm into the syndesm window 502. In some embodiments, each syndesm may be pre-assembled to the outside of the prosthetic heart valve frame 400. For example, in some embodiments, the pre-assembled syndesm may include two syndesm lugs of two adjacent leaflets (e.g., leaflets arranged adjacent to each other within the frame 400), folded into a desired configuration and secured together via one or more reinforcing (e.g., wedge-shaped) members and / or fasteners (e.g., sutures). The desired folded configuration of the syndesm lugs may include one or more overlapping syndesm lug layers, which can result in a more secure fit within the syndesm window and reduce the likelihood that the syndesm will be pulled and pulled out through the syndesm window after installation into the frame (e.g., during valve operation in vivo).

[0175] In some embodiments, the insertion of the coupling portion 424 into the coupling window 402 can be facilitated by the wider first portion 406. For example, the coupling portion 424 can be inserted into the first portion 406 first, and then slide and extend into the narrower and elongated second portion 408. In this way, a wider first width 418 can be selected to allow easy insertion of the coupling lug of the coupling portion 424 therein, and a narrower second width 422 can be selected to securely hold the coupling lug of the coupling portion 424 therein.

[0176] For example, a second length 420 and a second width 422 of the second portion 408 may be selected to accommodate the connecting portion 424 (e.g., having a length and width configured to tightly hold the connecting lug therein). Additionally, in some examples, a first length 416 and a first width 418 of the first portion 406 may be selected to allow the connecting portion to be inserted into the connecting portion window 402 during assembly (e.g., with reduced pneumatic force).

[0177] Furthermore, in some embodiments, the length 434 of the flexible strut portion 410 and the dimensions (e.g., the length and width described above) of the first and second portions of the strut frame 404 of the connecting window 402 can be selected to position the second portion 408 of the connecting window 402 closer to the lower portion of the elongation unit (e.g., elongation units 412a and 412b), thereby maintaining the first portion 408 (including the connecting portion 424) spaced apart from the upper edge 436 of the elongation unit. As a result, the leaflet can be positioned within the lower portion of the elongation unit with a lower profile configuration, while ensuring that the upper portion (or region) of the upper elongation unit is not obstructed. As discussed herein, this configuration allows for re-entry after a valve-in-valve procedure and / or ensures adequate blood flow through the upper elongation unit.

[0178] In some embodiments, the first length 416 minus twice the thickness of the frame 404 can be approximately 2 mm (e.g., the internal length of the first portion 406, or the length of the opening space), the first width 418 can be approximately 3 mm, and the second width 422 can be approximately 0.8 mm. In some embodiments, the first length 416 minus twice the thickness of the frame 404 can be in the range of 1.5-2.5 mm, the first width 418 can be in the range of 2.5-3.5 mm, and the second width 422 can be in the range of 0.6-1.0 mm. It should be noted that the above embodiments of the support frame dimensions are exemplary and not intended to be limiting.

[0179] return Figure 17 Method 500 can proceed from 504 to 506 to further bend the connecting window 402 (in which the connecting part is arranged) to a fully bent configuration, in which case the connecting window 402 is arranged substantially parallel to the axial support 70 (e.g., Figure 16 (As shown). In this fully curved configuration, the joining window 402 can be arranged radially inward relative to the central longitudinal axis of the frame 400 and the axial support 70. In some embodiments, the joining window 402 can be aligned with the central longitudinal axis of the joining window 402 in the transverse (or circumferential) direction. For example, as Figure 16 As shown, when in its fully curved configuration, the joint window 402 can be arranged directly in front of the axial support 70 relative to the radial direction.

[0180] Method 500 then proceeds to 508 to secure (e.g., attach) the lateral edge 426 (e.g., the lower edge in a fully curved configuration) of the second portion 408 of the joining window 402 to the frame 400. The lateral edge 426 is arranged opposite to the lateral edge 430 of the first portion 406. In some embodiments, securing the lateral edge 426 to the frame 400 includes securing the lateral edge 426 (e.g., via one or more fasteners such as one or more stitches 432, etc.) Figure 16 (as shown) to the lower support joint 428 and / or fixed to the support portion (e.g., angled support 64) extending from the lower support joint 428.

[0181] In some embodiments, method 500 may further include, at 510, after the connecting portion 424 has been arranged within the second portion 408, inserting a wedge or spacer into the first portion 406, as described above. In some embodiments, the wedge or spacer may be fastened (e.g., sewn) over the connecting lugs 82a and 82b. Thus, the connecting lugs 82a and 82b may be tightly wedged into the second portion 408 of the frame 404 of the connecting window 402, thereby preventing radial displacement of the connecting portion 424 within the connecting window 402. In some embodiments, the wedge or spacer may comprise a polymer or fabric material.

[0182] In this way, the above reference Figures 15-17 The discussed connector window and frame configuration is easier to manufacture and assemble because the connector of the leaflet can be pre-assembled to the outside of the frame and is easier to insert through the wider first part of the connector window. Furthermore, the ability to orient the connector window to any desired angle (relative to the frame) during assembly further simplifies the process of attaching the connector to the frame.

[0183] Furthermore, by reducing the number of individually attachable components, manufacturing costs can be further reduced by providing an integrally formed connecting window with the frame, and assembly time can be shortened. In addition, the integrally formed connecting window prevents undesirable relative movement between otherwise attachable components, which reduces or eliminates fretting corrosion of contact parts.

[0184] The above references Figures 5-17 The disclosed frame embodiment provides a prosthetic heart valve frame having integrally formed ferrule windows for the frame, the frame having upper ferrule units (e.g., arranged at the outflow end of the frame) that extend axially relative to the remaining ferrule units (e.g., lower ferrule units closer to the inflow end of the frame). As discussed above, these integral ferrule windows are configured to maintain the leaflet assembly of the valve in a lower position within the upper ferrule units, thereby creating clearance space through the upper ferrule units for increased blood flow and / or reentry devices.

[0185] In the alternative implementation, the frame of the prosthetic heart valve is as follows: Figure 2 and Figure 3 The frame 50 shown can be configured to receive a coupling support element. The coupling support element can be detached from the frame (e.g., not integral with the frame) and is configured to be coupled (e.g., attached) to a portion of the frame. Furthermore, the coupling support element can be configured to hold the coupling within an opening window of the coupling support element.

[0186] In one implementation, such as Figures 18-21The aforementioned provides a coupling support element 602 for attachment to a prosthetic heart valve frame 600. Specifically, the coupling support element 602 can be configured to attach to a unit in the upper row of elongated units of the frame 600 (e.g., forming...). Figure 2 and Figure 3 The unit with an elongated opening 76 in the frame 50. The fusion support element 602 may include a connecting portion adapted to connect to the upper edge of the upper row unit at the junction between two adjacent units of the upper row unit, and a leaflet receiving window with an opening adapted to receive the fusion portion therein. In some embodiments, a pre-assembled fusion portion assembled to the outside of the frame 600 can slide into the leaflet receiving window of the opening and be secured to the fusion support element 602, and then the fusion support element 602 can be attached to the frame, thereby simplifying the assembly and manufacturing process of the prosthetic heart valve. In addition, the fusion support element 602 may also be configured to arrange the fusion portion in the lower region of the upper row unit, so that the upper region of the upper row unit is not obstructed by the leaflets.

[0187] The joint support element 602 itself is displayed Figure 18 And attached to Figures 19-21 The frame 600 is included. The connecting support element 602 can be configured as an integral wire-form body 604, which includes a connecting portion 606 and a leaf-shaped receiving window 608 defined by axially extending first members 610 and second members 612 (e.g., first axial member and second axial member), and a connecting member 614 (which extends substantially laterally between the first axial member 610 and the second axial member 612). The connecting support element 602 is shown as being in... Figure 20 The central connecting part 620 is arranged inside the leaflet receiving window 608, while... Figure 19 and Figure 21 There is no connecting part (for better illustration of how the connecting part support element 602 is attached to the frame 600).

[0188] In some embodiments, the filament-type body 604 can be formed by known manufacturing processes such as tube cutting, 3D printing or other suitable processes.

[0189] In some implementations, such as Figure 18 As shown, each of the first axial member 610 and the second axial member 612 includes an upper axial portion 626 and a lower axial portion 628. For example, each lower axial portion 628 extends between the connecting member 614 and a bend 630 between the lower axial portion 628 and the upper axial portion 626. Each upper axial portion 626 extends between the bend 630 and a corresponding curved portion or member 622 or 624 (as further described below). Figure 18As shown, the width 632 between the lower axial portions 628 of each of the first axial member 610 and the second axial member 612 is wider than the width 634 between the upper axial portions 626 of each of the first axial member 610 and the second axial member 612. The width 632 is the width of the leaflet receiving window 608 (also called the joining window).

[0190] The connecting portion 606 may include a pair of connecting members 616 and 618 radially offset from the first axial member 610 and the second axial member 612. Connecting member 616 may be connected to the first axial member 610 via a curved portion or member 622, while connecting member 618 may be connected to the second axial member 612 via a curved portion or member 624. In some embodiments, the curved members 622 and 624 may be bent 180° such that the first axial member 610 and the second axial member 612 are parallel or substantially parallel to the connecting members 616 and 618, for example, extending toward the inlet end of the prosthetic heart valve, into which frame 600 is part, but other configurations are also possible.

[0191] In some implementations, such as Figure 18 As shown, the angular or circumferential spacing between connecting members 616 and 618 can be greater than the angular spacing between the upper axial portions 626 of the first axial member 610 and the second axial member 612. Therefore, the curved members 622 and 624 can be oriented at an angle to each other.

[0192] As described above, components 610, 612, and 614 may at least partially define the leaflet receiving window 608, which may be open at the top (e.g., at the end of the connecting support element 602 including curved components 622 and 624). As a result, in some embodiments, the assembled connecting portion may slide into the leaflet receiving window 608 through the space between the curved components 622 and 624 and through the space between the upper axial portions 626 (e.g., from above), as further described below.

[0193] Figures 19-21 A portion of an exemplary frame 600 is shown, which may be similar to Figure 2 and Figure 3 The frame 50, as described above. For example, the frame 600 may include multiple rows of units, wherein the first and second rows of units are arranged closer to the distal end 640 of the frame 600 (which may be the inflow end of the frame), including units 642 defined by four pillar portions extending between four joints or vertices (in Figures 19-21The example shown is a roughly rhomboid unit, but these units may take other shapes, for example, where the support portion is curved. The upper row of units arranged closer to the proximal end 644 of the frame (which may be the outflow end 54 of the frame 600) includes an elongated unit 646 defined by six support portions, two of which are elongated support portions, referred to herein as axial supports 70, extending axially on both sides of unit 646.

[0194] The frame 600 and other frames disclosed herein may include any other number of unit rows having units 642, provided that the upper (i.e., proximal) row includes an elongation unit 646. As described above, in some embodiments, this configuration may be used for valves of smaller diameters, wherein the elongation unit 646 provides a larger unit opening through which coronary reentry procedures can be performed.

[0195] like Figure 19 and Figure 20 As shown, the connecting support element 602 can be connected to the extension unit 646. More specifically, the connecting support element 602 can be connected to the angled pillar 66 forming the upper edge 648 of two adjacent extension units 646. For example, as Figure 19 and Figure 20 As shown, connecting members 616 and 618 are hooked around the angled post 66 of the two adjacent elongated units (for example, connecting member 616 is on the angled post 66 of the first elongated unit of the two adjacent elongated units 646, while connecting member 618 is on the angled post 66 of the second elongated unit of the two adjacent elongated units 646).

[0196] In this connection configuration, the connecting members 616 and 618 of the connecting support element 602 are positioned radially outside the frame 600 (relative 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 inside the frame 600. Additionally, in this connection configuration, the leaflet receiving window 608 is substantially positioned radially inside the elongated axial strut 70 (which forms part of each of the two adjacent elongated units connected by the connecting support element 602 or a common axial side). As a result, the axial strut 70 divides the leaflet receiving window 608 of the connecting support element 602 into two open window portions: a first window portion 650a, defined between the axial strut 70 and the lower axial portion 628 of the first axial member 610; and a second window portion 650b, defined between the axial strut 70 and the lower axial portion 628 of the second axial member 612.

[0197] like Figure 20As shown, the connecting lugs 82a and 82b of the connecting portion 620 can be inserted into the leaflet receiving window 608 (e.g., sliding down into the leaflet receiving window 608 from above before attaching the connecting portion support element 602 to the frame 600), such that the first connecting lug 82a extends through the first window portion 650a and the second connecting lug 82b extends through the second window portion 650b. For example, in some embodiments, the first connecting lug 82a and the second connecting lug 82b can be joined together to form the connecting portion 620. The formed connecting portion 620 can then be slid into the leaflet receiving window 608 of the connecting portion support element 602, while the connecting portion support element 602 is separate from the frame 600 (e.g., ...). Figure 18 (As shown). The coupling support element 602, which includes the coupling part 620, can then be connected to the frame, as shown. Figure 20 As shown.

[0198] In some embodiments, after the connecting support element 602 is attached to the frame 600, the connecting member 614 can be attached to the frame 600 using a first fastener (e.g., stitching) 652. In some embodiments, the connecting member 614 may be coupled to the lower support joint 654 of the frame 600 (e.g., ...). Figure 19 (As shown).

[0199] In some embodiments, a second fastener (e.g., one or more stitches) 656 may be used to secure the upper axial portions 626 of the first axial member 610 and the second axial member 612 and / or the connecting members 616 and 618 to the frame 600 (e.g., to the angled struts 66 forming the upper edges 648 of the two adjacent elongation units 646).

[0200] The axial length 658 of the lower axial portion 628 can be configured such that the first window portion 650a and the second window portion 650b, configured to receive the connecting lugs 82a and 82b of the connecting portion 620 respectively, are shorter than the length 660 of the axial strut 70. As a result, the connecting portion 60 is positioned within the lower region 670 of the elongation unit 646 such that the leaflets 84a and 84b do not obstruct the upper region 672 of the opening of the elongation unit. The unobstructed upper region of the elongation unit 646 can be large enough to allow sufficient blood flow to the coronary ostium after valve implantation and to allow a re-entry device to pass through it.

[0201] In alternative embodiments, the ferrule support element can be configured as relatively planar members, wherein the curved members 622 and 624 offset the connecting members 616 and 618 from the first axial member 610 and the second axial member 612 only in the lateral direction (e.g., not radially outward). In such embodiments, when the ferrule support element is attached to the frame, all portions of the ferrule support element, including the connecting members 616 and 618, reside along the inner surface of the frame 600 (e.g., in the same plane). In these embodiments, ferrule lug attachment and suture members around the frame can be performed in a manner similar to that described above. This configuration of the ferrule support element reduces the crease profile of the valve without extending the connecting members 616 and 618 outside the frame 600.

[0202] During the operation of the prosthetic heart valve with frame 600 in vivo, the leaflets of the valve can move from an open state during systole to a closed state during diastole. This constant cyclic movement of the leaflets may exert forces on the axial strut 70, potentially leading to fatigue and degradation of the material over time. Therefore, in some embodiments, such as Figure 21 As shown, the thickness 664 of the axial strut 662 configured to connect with the connecting part support element 602 can be greater than the thickness 668 of the axial strut 666 not configured to connect with the connecting part support element 602. Therefore, the thicker axial strut 666 is better suited to withstand increased stress.

[0203] In another implementation, such as Figures 22-24 As shown, frame 700 (e.g., similar to...) Figure 2 and Figure 3 The frame 50) – having an extension unit at the outlet end 54 of the frame 700 – may have an axial strut 702 including a strut window 704. For example, adjacent extension units share an axial strut extending between an upper extension strut joint 706 and a lower extension strut joint 708, the upper extension strut joint 706 being the joint between the lower ends of two angled struts 66 (e.g., disposed inside the outlet end 54 and furthest from the outlet end 54), and the lower extension strut joint 708 being the joint between the upper ends of two angled struts 64 (e.g., disposed closer to the outlet end 54). The axial struts of the upper row of units may be straight axial struts 70 (e.g., ...). Figure 2 and Figure 3 (as shown) or window axial support 702 (as shown) Figures 22-24As shown in the detailed view, the window axial strut 702 includes a strut window 704 configured to receive a coupling support element 710, which is configured to receive a coupling. For example, the frame 700 may include three window axial struts 702 (spaced apart from each other around the circumference of the annular frame 700), while the remaining axial struts forming the upper row of units are straight axial struts 70 (e.g., without strut windows 704). The number of axial struts 702 with strut windows 704 may correspond to the number of couplings in the leaflet assembly of the prosthetic heart valve. In alternative embodiments, the frame 700 may include more or fewer than three axial struts 702.

[0204] As further described below, the connector support element 710 may include a connecting portion adapted to be connected to the strut window 704 and a leaflet receiving window 734 with an opening adapted to receive the connector therein. In some embodiments, a pre-assembled connector assembled to the outside of the frame 700 may slide into the leaflet receiving window 734 and be secured to the connector support element 710, and then the connector support element 710 may be attached to the strut window 704 of the axial strut 702, thereby simplifying the assembly and manufacturing process of the prosthetic heart valve. Additionally, the strut window 704 may be positioned at a selected location along the length of the axial strut 702 to arrange the connector in the lower region of the elongated unit in the upper row of units, thereby leaving an upper region of the elongated unit in the upper row of units that is not obstructed by leaflets.

[0205] Figures 22-24 Detailed portions of an exemplary annular frame 700 are shown, including an axial support 702 comprising a support window 704, arranged between each of a first elongated unit 712a and a second elongated unit 712b in the upper row of units and forming its axial side. The first elongated unit 712a and the second elongated unit 712b are arranged adjacent to each other within the upper row of units of the frame 700. As discussed above, the remainder of the frame 700 may be similar to... Figure 2 and Figure 3 Framework 50 and / or other frameworks described herein. Figure 22 The bare frame 700 was displayed. Figure 23 The image shows the connecting support element 710 of the pillar window 704 attached to the frame 700, and... Figure 24 The image shows the connecting support element 710 attached to the support window 704—the connecting part is therein.

[0206] like Figure 22As shown, the axial strut 702 includes an upper (e.g., proximal) strut portion 714, a lower (e.g., distal) strut portion 716, and a strut window 704 disposed between the upper strut portion 714 and the lower strut portion 716. For example, the upper strut portion 714 extends axially between an upper extended strut joint 706 and a first transverse strut portion 718 of the strut window 704, while the lower strut portion 716 extends axially between a second transverse strut portion 720 of the strut window 704 and the lower extended strut joint 708.

[0207] The upper support portion 714 has a first length 728 and the lower support portion 716 has a second length 730. In some embodiments, such as Figure 22 As shown, the first length 728 is shorter than the second length 730. As further described below, the first length 728 and the second length 730 can be selected such that the support window 704 is spaced apart from the upper extended support joint 706, thereby positioning the leaflet joint in the lower region of the first extended unit 712a and the second extended unit 712b.

[0208] The first transverse support portion 718, the second transverse support portion 720, the first axial support portion 722, and the second axial support portion 724 of the support window 704 together form a closed support window 704 and define the central opening 726 of the support window 704. In this way, as... Figure 22 As shown, the pillar window 704 can be a closed rectangular frame with a central opening 726. However, in alternative embodiments, the pillar window 704 can have different shapes, such as rectangles, circles, squares, etc.

[0209] The support window 704 is configured to receive the connecting support element 710 (e.g., ...) within its central opening 726. Figure 23 and Figure 24 As shown). Figure 23 As shown, the connecting support element 710 can be configured as an integral wire-type body 732, which includes a connecting portion 707 configured to connect with the support window 704, a leaf-shaped receiving window 734 defined by axially extending first members 736 and second members 738 (e.g., first axial member and second axial member), and a connecting member 740 (which extends substantially laterally between the first axial member 736 and the second axial member 738). The connecting support element 710 is shown as... Figure 24 The connecting part 741 is arranged inside the leaflet receiving window 734, while Figure 23 There is no connecting part (for better illustration, how the connecting part support element 710 is attached to the frame 700).

[0210] In some embodiments, the filament-type body 732 can be formed by known manufacturing processes such as tube cutting, 3D printing or other suitable processes.

[0211] In some implementations, such as Figure 23 and Figure 24 As shown, the connecting portion may include a pair of connecting members 742 and 744 radially offset from the first axial member 736 and the second axial member 738. Connecting member 742 may be connected to the first axial member 736 via a curved portion or member 746, while connecting member 744 may be connected to the second axial member 738 via a curved portion or member 748. In some embodiments, connecting members 742 and 744 may be bent 180° such that the first axial member 736 and the second axial member 738 are parallel or substantially parallel to connecting members 742 and 744, for example, extending along the central longitudinal axis of the frame 700, but other configurations are also possible.

[0212] In some implementations, such as Figure 23 and Figure 24 As shown, the angular or circumferential spacing between the connecting members 742 and 744 can be smaller than the angular spacing between the first axial member 736 and the second axial member 738.

[0213] As described above, components 736, 738, and 740 may at least partially define the leaflet receiving window 734, which may be open at the top (e.g., at the end closest to the outflow end 54 of the frame 700 when the connecting support element 710 is attached to the pillar window 704). As a result, in some embodiments, the assembled connecting portion (e.g., connecting portion 741) may slide into the leaflet receiving window 608, as further described below.

[0214] like Figure 23 and Figure 24 As shown, the connecting support element 710 can be connected to the pillar window 704 by sliding the connecting members 742 and 744 through the central opening 726, such that the curved members 746 and 748 are placed in the second transverse pillar portion 720 of the pillar window 704 (which may form the lower edge of the pillar window 704).

[0215] When the connecting part support element 710 is connected to the pillar window 704, such as Figure 23 and Figure 24 As shown, the first axial member 736 and the second axial member 738 are arranged radially inside the frame 700 relative to the central longitudinal axis of the annular frame 700, while the connecting members 742 and 744 are arranged radially outside the frame 700.

[0216] The central opening 726 of the support window 704 can be sized (e.g., dimensioned) to receive the curved members 746 and 748 of the connecting support element 710. For example, in some embodiments, the width 750 of the central opening 726 (arranged in the lateral or circumferential direction) can be slightly smaller than the free-state distance between the outer edges of the curved members 746 and 748 (in the lateral direction). As a result, the user can slightly move the curved members 746 and 748 toward each other (e.g., via clamping) during insertion of the support window 704. In such an embodiment, after being positioned in the central opening 726, the curved members 746 and 748 can be laterally offset against the inner edges of the first axial portion 722 and the second axial portion 724 of the support window 704. As a result, the connecting support element 710 can be more securely held within the support window 704.

[0217] like Figure 23 As shown, the leaflet receiving window 734 of the connecting support element 710 can be arranged radially inside the lower support portion 716 (e.g., covering it), such that the lower support portion 716 divides the 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.

[0218] like Figure 24 As shown, the connecting lugs 82a and 82b can extend through the corresponding first window portion 734a and second window portion 734b, respectively. In some embodiments, before the connecting support element 710 is coupled to the frame 700, the connecting portion 741, including the connecting lugs 82a and 82b, is at least partially pre-assembled and inserted into the leaflet receiving window 734 of the connecting support element 710.

[0219] In some embodiments, a first fastener (e.g., a stitch) 752 may be used to secure the connecting member 740 of the joint support element 710 to the frame 700. For example, as Figure 23 As shown, the first fastener 752 can secure the connecting member 740 to the lower elongated support joint 708.

[0220] In some embodiments, additional stitching (not shown) may be used to secure the first axial member 736 and the second axial member 738 together and / or to secure the joint support element 710 to the strut window 704.

[0221] In some embodiments, wedge-shaped or spacer members (not shown) may be inserted between the curved members 746 and 748 and the first transverse support portion 718 of the support window 40 to reduce or prevent undesirable axial movement of the joint support element within the central opening 726.

[0222] In some embodiments, the first axial member 736 and the second axial member 738 of the connecting support element 710 are provided with a tapered cross-sectional geometry along the axial direction, such that their thickness increases toward their upper ends (e.g., the ends connected to the curved members 746 and 748). Such a configuration can help reduce the stress exerted on the leaflets during diastole.

[0223] In this manner, the frame 700 provides axial support to the joint support element 710, since both the upper and lower portions of the joint support element 710 are fixed to the frame 700. Furthermore, the disclosed strut window 704 further restricts undesirable axial displacement of the joint support element 710.

[0224] Other examples of the disclosed technology

[0225] In view of the above-described embodiments of the disclosed subject matter, this application discloses other examples listed below. It should be noted that a feature of a single example, or more than one feature of that example in combination, and optionally in combination with one or more features of one or more other examples, are also other examples that fall within the scope of this application's disclosure.

[0226] Example 1. A method of assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly, the method comprising: inserting a pre-assembled commissure, pre-assembled to the outside of the annular frame, into a commissure window of the frame via an opening in an upper or lower portion of a commissure window, wherein the commissure includes commissure lugs of adjacent leaflets of the leaflet assembly fixed together, wherein each commissure window is formed by one or more axially extending struts of two adjacent units in an upper row of units of the frame, the upper row of units being arranged at the outflow end of the frame and having an elongation relative to the units in the remaining rows of units of the frame in an axial direction relative to the central longitudinal axis of the frame; and securing the commissure within a commissure receiving portion of the commissure window via one or more fasteners, such that the commissure is arranged within a lower portion of the upper row of units and an opening region unobstructed by leaflets is formed within the upper portion of the upper row of units, the upper portion being arranged closer to the outflow end than the lower portion.

[0227] Example 2. Any example in this document, particularly the method of Example 1, wherein the connecting window is formed by two axially extending window pillars spaced apart from each other in a circumferential direction relative to the circumference of the annular frame, the first of the two axially extending window pillars forming the axial side of a first unit in the upper row of units, and the second of the two axially extending window pillars forming the axial side of an adjacent second unit in the upper row of units, wherein the connecting window includes a closed lower region of a connecting lug configured to receive the connecting portion and an upper region of an opening disposed at the outlet end of the frame, and wherein fixing the connecting portion to the connecting receiving portion of the connecting window includes arranging the connecting portion in the lower region of the connecting window and fixing the window fastener to the upper region of the connecting window via one or more fasteners.

[0228] Example 3. Any example in this document, particularly the method of Example 2, wherein securing a window fastener to the upper region includes first arranging the middle portion of the window fastener in the upper region of the connecting window such that a relatively constant distance is maintained between the two axially extending window pillars, and then wrapping one or more stitches around the ends of the window fastener, the ends being positioned radially inward and radially outward of the frame, the middle portion extending between the ends to secure the window fastener to the frame.

[0229] Example 4. Any example in this document, particularly the method of Example 1, wherein the connecting window is formed by two axially extending window pillars spaced apart from each other at their lower ends and along their length in a circumferential direction relative to the circumference of the annular frame, the lower ends of the two axially extending window pillars each being connected to a corresponding lower angled pillar of one of two adjacent units, wherein the two axially extending window pillars are connected together and connected at their upper ends to an upper axial pillar via the upper edge of the connecting window in a circumferential direction, wherein the upper axial pillar is connected at its upper end to an upper elongated pillar joint forming a joint between the upper angled pillars of the two adjacent units, and wherein allowing the connecting portion to slide through an opening includes allowing the connecting portion to slide through an opening formed in the lower portion of the connecting window between the spaced lower ends of the two axially extending window pillars.

[0230] Example 5. Any example in this document, particularly the method of Example 4, wherein securing the joint within the joint receiving portion of the joint window includes wrapping and tightening one or more fasteners around the lower clamping portions of two axially extending window pillars, the lower clamping portions forming an open neck region at the lower ends of the two axially extending window pillars such that the lower ends of the two axially extending window pillars are clamped together.

[0231] Example 6. Any example in this document, particularly the method of Example 1, wherein the connecting window is divided into a first-opening window portion and a second-opening window portion, each of the first-opening window portion and the second-opening window portion being configured to receive a different one of the connecting lugs of the connecting portion therein, wherein the first-opening window portion is formed between a central axially extending strut and a first axially extending strut arm, the central axially extending strut extending between upper and lower angled struts of two adjacent units, the first axially extending strut arm being connected to the axially extending strut at its lower end in a circumferential direction relative to the circumference of the annular frame and from... The axially extending strut is laterally biased, wherein a window portion of the second opening is formed between the axially extending strut and the second axial strut arm, the second axial strut arm being connected to the axially extending strut at its lower end and laterally biased from the axially extending strut, and wherein inserting the connecting portion into the connecting portion window via the opening includes inserting a first connecting portion lug of the connecting portion into the window portion of the first opening via an opening formed between the free upper end of the first axial strut arm and the axially extending strut, and inserting a second connecting portion lug of the connecting portion into the window portion of the second opening via an opening formed between the free upper end of the second axial strut arm and the axially extending strut.

[0232] Example 7. Any example in this document, particularly the method of Example 6, wherein securing the joint within the joint receiving portion of the joint window includes fastening fasteners around the free upper ends of the first axial strut arm and the second axial strut arm to clamp the first axial strut arm and the second axial strut arm together and clamp the axially extending strut.

[0233] Example 8. Any example in this document, particularly any of the methods in Examples 1-7, wherein the annular frame can be radially expanded to a diameter in the range of 19-21 mm.

[0234] Example 9. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining multiple rows of units arranged between an outflow end and an inflow end of the frame and including an upper row of units arranged at the outflow end and a lower row of units arranged at the inflow end, wherein units in the upper row of units are elongated relative to units in the remaining rows of units, including the lower row of units, in an axial direction relative to the central longitudinal axis of the frame; and a plurality of connecting windows formed between axially extending window struts of the frame, each connecting window being arranged in two adjacent elongated units in the upper row of openings. Between the axially extending window pillars of the unit, each connecting window has: a connecting receiving portion spaced apart from the upper ends of two adjacent elongated units, the upper ends of which are arranged at the outflow end of the frame; and an open end; and a leaf assembly comprising a plurality of leaflets, each leaflet including opposing connecting lugs on opposite sides of the leaflet, each connecting lug pairing with an adjacent connecting lug of an adjacent leaflet to form a connecting portion, wherein each connecting portion is arranged within the connecting receiving portion of the corresponding connecting window, and wherein the open end of the connecting window is configured to receive the connecting portion passing through it.

[0235] Example 10. Any example in this document, particularly the prosthetic heart valve of Example 9, wherein the opening end of each commissural window is formed by the upper or lower ends of axially extending window struts spaced apart from each other in the circumferential direction and not directly connected to each other, the circumferential direction being relative to the circumference of the frame and arranged to be tangent to the axial direction.

[0236] Example 11. A prosthetic heart valve of any of the examples in this document, particularly any one of Examples 9-10, wherein each fusion window is formed between a first axially extending window strut of a first elongated unit and a second axially extending window strut of a second elongated unit in two adjacent elongated units, the first and second axially extending window struts being spaced apart from each other at their upper ends and along their length and connected together at their lower ends by a transverse window strut portion, wherein each of the first and second axially extending window struts includes a lower window strut portion and an upper window strut portion, and wherein a fusion receiving portion of the fusion is formed in the space between the lower window strut portion of the first and second axially extending window struts.

[0237] Example 12. Any example in this document, particularly the prosthetic heart valve of Example 9 or Example 10, wherein each merging window is formed between a first axially extending window strut and a second axially extending window strut, the first axially extending window strut and the second axially extending window strut being spaced apart from each other at their lower ends and along their length in the circumferential direction, the lower end of each of the first axially extending window strut and the second axially extending window strut being connected to a corresponding lower angled strut of one of two adjacent elongation units, wherein the first axially extending window strut and the second axially extending window strut are connected together and connected at their upper ends to an upper axial strut via the upper edge of the merging window in the circumferential direction, and wherein the upper axial strut is connected at its upper end to an upper elongation strut joint forming a joint between the upper angled struts of the two adjacent elongation units.

[0238] Example 13. Any example in this document, particularly the prosthetic heart valve of Example 9 or Example 10, wherein each fusion window is divided into a first-opening window portion and a second-opening window portion, each of the first-opening window portion and the second-opening window portion being configured to receive a different one of the fusion lugs of the fusion portion therein, wherein the first-opening window portion is formed between a centrally axially extending strut and a first axial strut arm, the first axial strut arm being connected to and laterally offset from the lower end of the axially extending strut in a circumferential direction relative to the circumference of the frame, wherein the second-opening window portion is formed between the axially extending strut and the second axial strut arm, the second axial strut arm being connected to and laterally offset from the lower end of the axially extending strut, and wherein each of the first axial strut arm and the second axial strut arm includes a free upper end configured to be displaced laterally and radially relative to the axially extending strut by one or more.

[0239] Example 14. Any example in this document, particularly the prosthetic heart valve of Example 13, wherein an axially extending strut extends between a lower elongated strut joint and an upper elongated strut joint of a frame, the lower elongated strut joint being a joint between two adjacent elongated units arranged at the outflow end of the frame with first two angled struts, and the upper elongated strut joint being a joint between two adjacent elongated units with second two angled struts arranged at the ends of the two adjacent elongated units opposite to the first two angled struts.

[0240] Example 15. Any example in this article, particularly any one of Examples 9-14, of a prosthetic heart valve in which the annular frame can be radially expanded to an expanded configuration.

[0241] Example 16. Any example in this article, particularly the prosthetic heart valve of Example 15, wherein the expansion configuration has a diameter of 20 mm.

[0242] Example 17. Any example in this article, particularly the prosthetic heart valve of Example 15, wherein the expansion configuration has a diameter in the range of 19-21 mm.

[0243] Example 18. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining a multi-row unit, the multi-row unit being disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end that extends axially relative to the units in the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame; and a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural; wherein the struts defining the upper row unit further define a plurality of open commissural windows, the plurality of open commissural windows being open at an upper end and formed between adjacent elongated units in the upper row unit, each commissural window being formed between two axially extending window struts spaced apart from each other in a circumferential direction, each commissural window including a lower region of a commissural lug configured to receive a commissural and an upper region disposed at the outflow end of the frame.

[0244] Example 19. Any example in this document, particularly the prosthetic heart valve of Example 18, wherein each of the two axially extending window struts defines the axial side of a different elongated unit in two adjacent elongated units in the upper row of units.

[0245] Example 20. Any of the examples in this document, particularly any one of Examples 18-19, of a prosthetic heart valve, wherein each commissural window is partially closed at its lower end by a transverse window strut portion connecting the lower ends of two axially extending window struts arranged opposite to the upper end in the axial direction.

[0246] Example 21. Any example in this document, particularly the prosthetic heart valve of Example 20, wherein the transverse window strut portion is also connected to an angled strut defining a portion of a unit in a second row of adjacent upper unit arrangements.

[0247] Example 22. Any of the examples in this document, particularly any one of Examples 18-21, of a prosthetic heart valve, wherein each of the two axially extending window struts of each commissural window includes a lower window strut portion and an upper window strut portion, wherein a first gap between the upper window strut portions of the two axially extending window struts forms an upper region of the commissural window, and wherein a second gap between the lower window strut portions of the two axially extending window struts forms a lower region of the commissural window.

[0248] Example 23. Any example in this document, particularly Example 22, of a prosthetic heart valve, wherein each upper window strut portion includes a recessed portion and wherein a first gap is larger than a second gap.

[0249] Example 24. Any of the examples in this document, particularly the prosthetic heart valves of Examples 22 and 23, also includes window fasteners positioned in the upper region of each merging window and configured to maintain a relatively constant distance between the two axially extending window struts.

[0250] Example 25. Any example in this document, particularly the prosthetic heart valve of Example 24, wherein the window fastener includes a central portion and two opposing ends, the central portion extending between the two ends, the width of the two ends being wider than the width of the central portion, the width being arranged in a circumferential direction.

[0251] Example 26. Any example in this document, particularly the prosthetic heart valve of Example 25, wherein the middle portion is arranged within a first gap, the first end of the two ends extends radially outward and laterally along the upper window strut portion of the two axially extending window struts and circumferentially between the radially outward and laterally extending window struts, while the second end of the two ends extends radially inward and laterally along the upper window strut portion and circumferentially between the radially inward and laterally extending window struts.

[0252] Example 27. Any example in this document, particularly Example 25, is a prosthetic heart valve in which the transverse edges at both ends include a plurality of notches adapted to receive fasteners therein.

[0253] Example 28. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining multiple rows of units arranged between an outflow end and an inflow end of the frame and including an upper row of units arranged at the outflow end that are axially elongated relative to the units in the remaining rows of units, the axial direction being relative to the central longitudinal axis of the frame; and a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural portion; wherein the struts defining the upper row of units further define a plurality of open commissural portions. The window, a plurality of openings, is open at the lower end and formed within the lower portion of the adjacent elongated units in the upper row of units. Each joint window is configured to receive the joint therein and is formed by two axially extending window pillars spaced apart from each other in the circumferential direction. The two axially extending window pillars are connected via the upper edge of the joint window to an upper axial pillar and to a lower angled pillar of the upper row of units. The upper axial pillar and the two axially extending window pillars together form an axially extending pillar that defines the axial side of each of the two adjacent elongated units.

[0254] Example 29. Any example in this document, particularly the prosthetic heart valve of Example 28, wherein the upper axial strut and two axially extending window struts each extend in an axial direction, wherein the upper edge of the connecting window extends perpendicular to the upper axial strut, and wherein the circumferential direction is relative to the circumference of the frame.

[0255] Example 30. Any of the examples in this article, particularly any one of Examples 28-29, is a prosthetic heart valve in which the upper edge is spaced from the outflow end of the frame by an upper axial strut.

[0256] Example 31. Any of the examples in this document, particularly any one of Examples 28-30, is a prosthetic heart valve in which an upper axial strut is arranged between an upper elongated strut joint and an upper edge, the upper elongated strut joint forming a joint between two angled struts arranged at the outflow end of the frame, each of the two angled struts at least partially forming the upper side of a corresponding one of the two adjacent elongated units.

[0257] Example 32. Any of the examples in this document, particularly any one of Examples 28-31, is a prosthetic heart valve in which each of the two axially extending window struts includes a lower clamping portion, wherein the lower clamping portions of the two axially extending window struts are angled toward each other and define an opening therebetween, the opening being the lower opening of the connecting window.

[0258] Example 33. Any example in this document, particularly Example 32, of a prosthetic heart valve, wherein an outwardly curved portion in the lower clamping portion of two axially extending windows forms a neck region configured to receive fasteners.

[0259] Example 34. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining a multi-row unit, the multi-row unit being disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end that extends axially relative to the units of the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame; and a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural; wherein the struts defining the upper row unit further define a plurality of open commissural windows, each commissural window being open at an upper end and formed between two adjacent elongated units in the upper row unit. Within the lower portion of two adjacent elongated units, each connecting window is divided into a first-opening window portion and a second-opening window portion. Each of the first-opening window portion and the second-opening window portion is configured to receive a different one of the connecting lugs of the connecting portion therein. The first-opening window portion is formed between a central axially extending strut and a first axial strut arm, the first axial strut arm being connected to the axially extending strut in a circumferential direction relative to the circumference of the frame and laterally offset from the axially extending strut. The second-opening window portion is formed between the axially extending strut and the second axial strut arm, the second axial strut arm being connected to the axially extending strut and laterally offset from the axially extending strut.

[0260] Example 35. Any example in this document, particularly the prosthetic heart valve of Example 34, wherein an axially extending strut extends between a lower elongated strut joint and an upper elongated strut joint of a frame, the lower elongated strut joint being a joint between two adjacent elongated units arranged at the outflow end of the frame with first two angled struts, and the upper elongated strut joint being a joint between two adjacent elongated units with second two angled struts arranged at the ends of the two adjacent elongated units opposite to the first two angled struts.

[0261] Example 36. Any example in this document, particularly Example 35, of a prosthetic heart valve, wherein a first axial strut arm and a second axial strut arm are arranged on opposite sides of an axially extending strut and the arrangement of the axially extending strut is connected to the axially extending strut at the lower end of the lower elongated strut joint.

[0262] Example 37. Any example in this document, particularly the prosthetic heart valve of Example 35, wherein each of the first axial strut arm and the second axial strut arm includes an axial portion of a strut extension parallel to the axial extension and a transverse portion extending between the lower elongated strut joint and the axial portion.

[0263] Example 38. Any example in this article, particularly the prosthetic heart valve of Example 37, wherein the transverse portion is arranged perpendicular to the axial portion.

[0264] Example 39. Any of the examples in this document, particularly the prosthetic heart valves of Examples 37 and 38, wherein each of the first axial strut arm and the second axial strut arm further includes an upper clamping portion extending upward from the axial portion toward the outflow end of the frame, and wherein the upper clamping portions of the first axial strut arm and the second axial strut arm form a narrower neck region at the upper end of the opening of the merging window.

[0265] Example 40. Any of the examples in this document, particularly any one of Examples 35-39, is a prosthetic heart valve, wherein each of the first axial strut arm and the second axial strut arm includes a lower end directly connected to the lower end of the axially extending strut at a lower elongated strut junction and an upper end free and configured to be laterally and / or radially displaced relative to the axially extending strut.

[0266] Example 41. A prosthetic heart valve comprising: an annular frame including: a plurality of interconnected struts defining a multi-row unit, the multi-row unit being disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end and a lower row unit disposed at the inflow end, wherein a unit in the upper row unit is elongated relative to the units in the remaining rows of units, including the lower row unit, in an axial direction relative to the central longitudinal axis of the frame; and a plurality of connecting windows, each connecting window being defined by a closing frame including a wider first portion and a narrower second portion, the first portion being connected to an upper elongated strut of the frame via a flexible strut portion. The column joint, the upper extended column joint being the joint between two angled columns of two adjacent extended units in the upper row of units; and an axially extending column arranged between two adjacent extended units, wherein the joint window is configured to bend from the extended configuration to a bent configuration where the joint window overlaps with the axially extending column via its flexible column portion; and a leaflet assembly comprising a plurality of leaflets, each leaflet including opposing joint lugs on opposite sides of the leaflet, each joint lug pairing with an adjacent joint lug of an adjacent leaflet to form a joint, wherein each joint is arranged within a corresponding second portion of the corresponding joint window.

[0267] Example 42. Any example in this document, particularly Example 41, of a prosthetic heart valve, wherein the upper elongated strut joint is arranged at the outflow end of the frame, and wherein when the joint window is in the extended configuration, its axially outward and away from the outflow end of the frame extends.

[0268] Example 43. Any of the examples in this document, particularly any one of Examples 41-42, is a prosthetic heart valve in which a flexible strut portion is configured to bend from an extended configuration to a bent configuration via manual force, and wherein the flexible strut portion comprises a malleable material.

[0269] Example 44. Any example in this document, particularly any one of Examples 41-43, of a prosthetic heart valve, wherein the flexible strut portion is axially aligned with the axially extending strut.

[0270] Example 45. Any of the examples in this document, particularly any of Examples 41-44, of a prosthetic heart valve, also includes a wedge-shaped element disposed within the first portion.

[0271] Example 46. Any example in this article, particularly any one of Examples 41-45, of a prosthetic heart valve, wherein the first part is shorter than the second part.

[0272] Example 47. A method for assembling a prosthetic heart valve comprising an annular frame and a leaflet assembly, the method comprising: bending a ferrule window of the annular frame to a first bending orientation between a fully extended configuration and a fully bent configuration, wherein the ferrule 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 flexible strut portion to an upper elongated strut joint of the annular frame, the upper elongated strut joint being a joint between two angled struts of two adjacent elongated units arranged in the outflow end of the annular frame; and an axially extending strut arranged between two adjacent elongated units, wherein in the fully extended configuration... In the form of the flexible support portion, the flexible support portion is not bent and the connecting window extends axially outward relative to the central longitudinal axis of the annular frame and away from the outflow end of the annular frame, wherein in the fully bent configuration, the connecting window overlaps with the axially extending support; the connecting portion, which is at least partially pre-assembled to the outside of the annular frame, is inserted into the connecting window, wherein the connecting portion includes connecting lugs of adjacent leaflets of the leaflet assembly fixed together; the connecting window is bent to the fully bent configuration such that the connecting window extends parallel to the axially extending support and is arranged radially inside the axially extending support; and the connecting window is fixed to the annular frame in its fully bent configuration.

[0273] Example 48. Any example in this document, particularly the method of Example 47, wherein securing the joint window to the annular frame includes securing the lateral edge of the second portion of the joint window to the annular frame.

[0274] Example 49. Any example in this document, particularly any of Examples 47-48, wherein the elongated units in the upper row of elongated units are elongated relative to the units in the remaining rows of units of the adjacent annular frame, the remaining rows being arranged further from the outlet than the upper row of elongated units.

[0275] Example 50. Any example in this document, particularly any of Examples 47-49, wherein inserting the connector involves first inserting the connector into a first portion of the support frame of the connector window, and then sliding the connector into a second portion of the support frame of the connector window.

[0276] Example 51. Any of the examples in this document, particularly any of Examples 47-50, further includes inserting a wedge element into a first portion of the connecting window to further secure the connecting portion within a second portion of the connecting window.

[0277] Example 52. A method of assembling a prosthetic heart valve comprising a ring frame and a leaflet assembly, the method comprising: inserting a commissure, at least partially pre-assembled to the outside of the ring frame, through an opening in a leaflet receiving window of a commissure support element into the leaflet receiving window, wherein the commissure includes commissure lugs of adjacent leaflets of the leaflet assembly fixed together, wherein the leaflet receiving window is formed by at least a portion of two axially extending members of the commissure support element that are open at a first end and connected at opposite second ends by a connecting member, and wherein the commissure support element includes a coupling The portion includes a connecting portion connected to the leaflet receiving window and adapted to be connected to a portion of two adjacent units in the upper row of units forming the annular frame, the upper row of units being arranged at the outflow end of the annular frame and having a length that extends relative to the units in the remaining rows of units in the annular frame in an axial direction relative to the central longitudinal axis of the annular frame; and a connecting portion support element attached to the portion of the annular frame such that the leaflet receiving window and the connecting portion arranged therein are arranged in the lower portion of the upper row of units and an opening area not blocked by the leaflet is formed in the upper portion of the upper row of units.

[0278] Example 53. Any example in this document, particularly the method of Example 52, wherein attaching the connecting support element to the portion of the annular frame includes attaching the connecting support element to two adjacent units and arranging the leaflet receiving window relative to the central longitudinal axis inside an axial strut forming the common axial side of each of the two adjacent units.

[0279] Example 54. Any example in this document, particularly the method of Example 53, further includes securing the connecting member of the joint support element to the lower extension strut joint of the upper row unit via one or more fasteners, the lower extension strut joint being the joint between the lower ends of two angled struts forming the lower edges of two adjacent units and the axial strut.

[0280] Example 55. Any example in this document, particularly the method of Example 53 or Example 54, wherein the connecting portion of the connecting support element includes a pair of connecting members, each connected to one of the two axially extending members via a different curved member of the two curved members of the connecting support element.

[0281] Example 56. Any example in this document, particularly the method of Example 55, wherein attaching the connecting support element to the portion of the annular frame comprises hooking two curved members around the upper edges of two adjacent units, the upper edges being arranged at the outflow end of the frame and formed by two angled pillars of the two adjacent units.

[0282] Example 57. Any example in this document, particularly the method of Example 56, further includes securing the joint support element to the annular frame by securing one or more fasteners around the upper axial portions of the paired connecting members and the two axially extending members of the joint support element, wherein the upper axial portions extend from the lower axial portions of the two axially extending members, the two lower axial portions forming a leaflet receiving window.

[0283] Example 58. Any example in this document, particularly the method of Example 55, wherein attaching the connecting support element to the portion of the annular frame includes passing two curved members through the central opening of the support window of the axial strut and hooking them around the lower transverse strut portion of the support window, wherein the support window is a closed window formed by a plurality of connected strut portions including the lower transverse strut portion, and is arranged along the length of the axial strut at a distance from the junction between the upper edge of the two adjacent units and the angled strut at the upper end of the axial strut.

[0284] Example 59. Any example in this document, particularly the method of Example 58, wherein attaching the connecting support element to the annular frame further includes clamping the two curved members toward each other while simultaneously inserting the paired connecting members through the central opening of the pillar window, and releasing the two curved members after inserting the paired connecting members through the central opening such that the two curved members hook around the lower transverse pillar portion of the pillar window, such that they are laterally offset against the inner edge of the axial pillar portion of the pillar window.

[0285] Example 60. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining a multi-row unit disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end that extends axially relative to the units in the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame; a plurality of leaflets located within the frame, each leaflet including opposing merging lugs on opposite sides of the leaflet, each merging lug pairing with an adjacent merging lug of an adjacent leaflet to form a merging portion; and at least one merging portion support element including a connecting portion and two axially extending members radially offset from the connecting portion and laterally spaced from each other to form a leaflet receiving window configured to receive an opening of the merging portion, wherein the connecting portion is configured to connect to the upper edges of two adjacent units in the upper row unit, the upper edges being disposed at the outflow end of the frame, and wherein the leaflet receiving window is spaced axially from the upper edges.

[0286] Example 61. Any example in this document, particularly Example 60, of a prosthetic heart valve, wherein the upper edges of two adjacent units are formed by two angled struts of the two adjacent units, and wherein the lower ends of the two angled struts are each connected to an axial strut forming a common axial side of each of the two adjacent units, the axial struts being arranged parallel to the central longitudinal axis.

[0287] Example 62. Any example in this document, particularly the prosthetic heart valve of Example 61, wherein the leaflet receiving window is arranged radially inside the axial strut when the merging support element is attached to the upper edge of two adjacent units in the upper row of units.

[0288] Example 63. Any example in this document, particularly Example 62, of a prosthetic heart valve, wherein the axial strut divides the leaflet receiving window into two open windows, each of the two window portions being defined between the axial strut and a different one of two axially extending members, and wherein each of the two window portions is configured to receive a corresponding one of the opposing connecting lugs of the connecting portion.

[0289] Example 64. Any example in this document, particularly any one of Examples 60-63, of a prosthetic heart valve, wherein the connecting portion comprises a pair of connecting members, each connected to one of two axially extending members by different curved members of two curved members of the connecting portion support element, and wherein when the connecting portion is connected to the upper edge of two adjacent units, the pair of connecting members are arranged radially outside the frame relative to the central longitudinal axis and the two axially extending members are arranged radially inside the frame.

[0290] Example 65. Any of the examples in this document, particularly any one of Examples 60-64, of a prosthetic valve, wherein the leaflet receiving window is further defined by a connecting member extending between two axially extending members, forming a closed end at a first end of the lower portion of the leaflet receiving window, and wherein the second end of the opposite upper portion of the leaflet receiving window is open and configured to receive the suture portion therethrough.

[0291] Example 66. Any example in this document, particularly any one of Examples 60-65, of a prosthetic heart valve, wherein the connecting portion includes a pair of connecting members, each connected to one of two axially extending members by different curved members of two curved members of the connecting portion support element, and wherein each curved member is configured to bend and hook around the upper edge of two adjacent units in the upper row of units.

[0292] Example 67. Any example in this document, particularly the prosthetic heart valve of Example 66, wherein each of the two axially extending members includes an upper axial portion and a lower axial portion, each lower axial portion extending between a connecting member and a bend between the lower axial portion and the upper axial portion, and each upper axial portion extending between the bend and a corresponding curved member of the two curved members, wherein a first width between the lower axial portions of the two axially extending members is wider than a second width between the upper axial portions of the two axially extending members, and wherein the second width is the width of the leaflet receiving window.

[0293] Example 68. Any of the examples in this document, particularly any one of Examples 60-67, is a prosthetic heart valve in which the commissure support element is secured to the frame via one or more fasteners.

[0294] Example 69. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining a multi-row unit, the multi-row being arranged between an outflow end and an inflow end of the frame and including an upper row unit arranged at the outflow end that extends axially relative to the units in the remaining rows of the multi-row unit, the axial direction being relative to the central longitudinal axis of the frame, wherein the struts defining the upper row unit include a plurality of axial struts, each axial strut forming a common axial side of two adjacent units in the upper row unit, and wherein a portion of the plurality of axial struts is a window axial strut, each window axial strut... The device includes a closed pillar window positioned at a distance from the upper end of the pillar along the length of the pillar along the window axis; a plurality of leaflets located within a frame, each leaflet including opposing connecting lugs on opposite sides of the leaflet, each connecting lug pairing with an adjacent connecting lug of an adjacent leaflet to form a connecting portion; and at least one connecting portion support element including a connecting portion and two axially extending members, the two axially extending members being radially offset from the connecting portion and laterally spaced apart from each other to form a leaflet receiving window configured to receive an opening of the connecting portion, wherein the connecting portion is configured to connect to the pillar window.

[0295] Example 70. Any example in this document, particularly the prosthetic heart valve of Example 69, wherein when the merging support element is connected to the strut window of the window axial strut, the leaflet receiving window is positioned radially inward of the lower strut portion of the window axial strut, the strut window is arranged between the lower strut portion and the upper strut portion of the window axial strut, the lower strut portion being connected to an angled strut forming the lower edge of two adjacent units in the upper row of units, and the upper strut portion being connected to an angled strut forming the upper edge of two adjacent units.

[0296] Example 71. Any example in this document, particularly Example 70, of a prosthetic heart valve, wherein the length of the upper strut portion is shorter than the length of the lower strut portion, and wherein the length of the lower strut portion corresponds to the length of the leaflet receiving window of the commissural support element.

[0297] Example 72. Any of the examples in this document, particularly any one of Examples 69-71, of a prosthetic heart valve, wherein the distance between the closed strut window and the upper end of the window axial strut is selected such that, when the connecting support element is connected to the strut window, the leaflet receiving window is positioned closer to the lower end of the two adjacent units than the upper end of the two adjacent units, the upper end being arranged at the outflow end of the annular frame.

[0298] Example 73. Any of the examples in this document, particularly any one of Examples 69-72, is a prosthetic heart valve in which the connecting portion of the merging support element includes a pair of connecting members radially offset from two axially extending members, the pair of connecting members including a first connecting member connected to the first axial member of the two axially extending members by a first curved member and a second connecting member connected to the second axial member of the two axially extending members by a second curved member.

[0299] Example 74. Any example in this document, particularly Example 73, of a prosthetic heart valve, wherein the strut window includes a plurality of connected strut portions defining a central opening of the strut window, the width of the central opening being sized to receive a first curved member and a second curved member.

[0300] Example 75. Any example in this document, particularly the prosthetic heart valve of Example 74, wherein the width of the central opening is equal to or less than the free-state distance between the outer edges of the first and second curved members.

[0301] Example 76. A prosthetic heart valve comprising: an annular frame including: a plurality of interconnected struts defining a multi-row unit, the multi-row being arranged between an outflow end and an inflow end of the frame and including an upper row unit arranged at the outflow end and a lower row unit arranged at the inflow end, wherein units in the upper row unit are elongated relative to units in the remaining rows of units, including the lower row unit, in an axial direction relative to the central longitudinal axis of the frame; and a plurality of connecting windows formed between axially extending window struts of the frame, each connecting window being arranged between two adjacent elongated window struts of the upper row opening unit, each connecting window having a... The upper ends of two adjacent elongated units are spaced apart by a connecting portion receiving portion, the upper end of which is arranged at the outlet end of the frame; and a leaf assembly including a plurality of leaflets, each leaflet including opposing connecting portion lugs on opposite sides of the leaflet, each connecting portion lug being paired with an adjacent connecting portion lug of an adjacent leaflet to form a connecting portion, wherein each connecting portion is arranged within a connecting portion receiving portion of a corresponding connecting portion window, and wherein when each connecting portion is arranged within a connecting portion receiving portion of a corresponding connecting portion window, the connecting portion is arranged within a lower portion of the upper row unit and an opening area not blocked by the leaflets is formed within the upper portion of the upper row unit, the upper portion being arranged closer to the outlet end than the lower portion.

[0302] Example 77. A prosthetic heart valve comprising: an annular frame including: a plurality of interconnected struts defining a multi-row unit arranged between an outflow end and an inflow end of the frame and including an upper row unit arranged at the outflow end and a lower row unit arranged at the inflow end; and a plurality of coupling windows formed between axially extending window struts of the frame, each coupling window being arranged between axially extending window struts of two adjacent units in the upper row unit, each coupling window having a coupling receiving portion spaced from the upper ends of the two adjacent units, the upper end being arranged at the outflow end of the frame, each coupling window having an open end; and a leaflet assembly including a plurality of leaflets, each leaflet including opposing coupling lugs on opposite sides of the leaflet, each coupling lug pairing with an adjacent coupling lug of an adjacent leaflet to form a coupling, wherein each coupling is arranged within a coupling receiving portion of a corresponding coupling window, and wherein the open end of the coupling window is configured to receive a coupling passing therethrough.

[0303] Example 78. Any example in this document, particularly the prosthetic heart valve of Example 77, wherein the opening end of each commissural window is formed by the upper or lower ends of axially extending window struts spaced apart from each other in the circumferential direction and not directly connected to each other, the circumferential direction being relative to the circumference of the frame and arranged to be tangent to the axial direction.

[0304] Example 79. Any example in this document, particularly the prosthetic heart valve of Example 77 or 78, wherein each fusion window is formed between a first axially extending window strut of a first unit in two adjacent units and a second axially extending window strut of a second unit in two adjacent units, the first and second axially extending window struts being spaced apart from each other at their upper ends and along their length and connected together at their lower ends by a transverse window strut portion, wherein each of the first and second axially extending window struts includes a lower window strut portion and an upper window strut portion, and wherein a fusion receiving portion of the fusion is formed in the space between the lower window strut portion of the first and second axially extending window struts.

[0305] Example 80. Any example in this document, particularly the prosthetic heart valve of Example 77 or 78, wherein each merging window is formed between a first axially extending window strut and a second axially extending window strut, the first axially extending window strut and the second axially extending window strut being spaced apart from each other at their lower ends and along their length in the circumferential direction, the lower end of each of the first axially extending window strut and the second axially extending window strut being connected to a corresponding lower angled strut in two adjacent units, wherein the first axially extending window strut and the second axially extending window strut are connected together and connected at their upper ends to an upper axial strut via the upper edge of the circumferentially extending merging window, and wherein the upper axial strut is connected at its upper end to an upper strut joint forming a joint between the upper angled struts of two adjacent units.

[0306] Example 81. Any example in this document, particularly the prosthetic heart valve of Example 77 or 78, wherein each fusion window is divided into a first-opening window portion and a second-opening window portion, each of the first-opening window portion and the second-opening window portion being configured to receive a different one of the fusion lugs of the fusion portion therein, wherein the first-opening window portion is formed between a centrally axially extending strut and a first axial strut arm, the first axial strut arm being connected to and laterally offset from the lower end of the axially extending strut in a circumferential direction relative to the circumference of the frame, wherein the second-opening window portion is formed between the axially extending strut and the second axial strut arm, the second axial strut arm being connected to and laterally offset from the lower end of the axially extending strut, and wherein each of the first axial strut arm and the second axial strut arm includes a free upper end configured to be displaced laterally and radially relative to the axially extending strut by one or more.

[0307] Example 82. Any example in this document, particularly the prosthetic heart valve of Example 81, wherein an axially extending strut extends between a lower strut joint and an upper strut joint of a frame, the lower strut joint being a joint between two adjacent units arranged at the outflow end of the frame with first two angled struts, and the upper strut joint being a joint between two adjacent units with second two angled struts arranged at the ends of the two adjacent units opposite to the first two angled struts.

[0308] Example 83. Any of the examples in this article, particularly any one of Examples 77-82, is a prosthetic heart valve in which the annular frame can be radially expanded to an expanded configuration.

[0309] Example 84. Any of the examples in this paper, particularly any of Examples 77-83, is a prosthetic heart valve in which the units in the upper row are elongated in the axial direction relative to the units in the lower row.

[0310] Example 85. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts defining a multi-row unit disposed between an outflow end and an inflow end of the frame and including an upper row unit disposed at the outflow end; and a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural; wherein the struts defining the upper row unit further define commissural windows that are open at their upper ends and form openings between adjacent units in the upper row unit, each commissural window being formed between two axially extending window struts spaced apart from each other in a circumferential direction, each commissural window including a lower region of a commissural lug configured to receive a commissural.

[0311] Example 86. Any example in this document, particularly Example 85, of a prosthetic heart valve, wherein each of two axially extending window struts defines the axial side of a distinct unit in two adjacent units in the upper row of units.

[0312] Example 87. Any example in this document, particularly the prosthetic heart valve of Example 85 or 86, wherein each commissural window is partially closed at its lower end by a transverse window strut portion connecting the lower ends of two axially extending window struts arranged opposite to the upper end in the axial direction.

[0313] Example 88. Any example in this document, particularly Example 87, of a prosthetic heart valve, wherein the transverse window strut portion is also connected to an angled strut defining a portion of a unit in a second row of adjacent upper unit arrangements.

[0314] Example 89. Any example in this document, particularly any one of Examples 85-88, of a prosthetic heart valve, wherein each of the two axially extending window struts of each commissural window includes a lower window strut portion and an upper window strut portion, wherein a first gap between the upper window strut portions of the two axially extending window struts forms an upper region of the commissural window, wherein a second gap between the lower window strut portions of the two axially extending window struts forms a lower region of the commissural window, wherein each upper window strut portion includes a recessed portion, and wherein the first gap is greater than the second gap.

[0315] Example 90. Any example in this document, particularly the prosthetic heart valve of Example 89, also includes a window fastener positioned in the upper region of each merging window and configured to maintain a relatively constant distance between the two axially extending window struts.

[0316] Example 91. Any example in this document, particularly Example 90, of a prosthetic heart valve, wherein the window fastener includes a central portion and two opposing ends, the central portion extending between the two ends, the width of the two ends being wider than the width of the central portion, the width being arranged in a circumferential direction, and wherein the central portion is arranged within a first gap, the first end of the two ends extending circumferentially between the radially outward and laterally extending upper window support portions of two axially extending window supports, while the second end of the two ends extending circumferentially between the radially inward and laterally extending upper window support portions.

[0317] Example 92. A prosthetic heart valve, comprising: an annular frame including a plurality of interconnected struts defining a multi-row unit arranged between an outflow end and an inflow end of the frame and including an upper row unit arranged at the outflow end; and a plurality of leaflets located within the frame, each leaflet including opposing commissural lugs on opposite sides of the leaflet, each commissural lug pairing with an adjacent commissural lug of an adjacent leaflet to form a commissural portion; wherein the struts defining the upper row unit further define commissural windows forming a plurality of openings between adjacent units in the upper row unit, each commissural window being configured to receive the commissural portion therein and formed by two axially extending window struts spaced apart from each other in a circumferential direction, wherein the commissural window is axially offset toward the upstream / inflow end of the upper row unit.

[0318] Example 93. Any example in this document, particularly the prosthetic heart valve of Example 92, wherein two axially extending window struts are connected to an upper axial strut via the upper edge of a connecting window and to a lower angled strut of an upper row of units, the upper axial strut and the two axially extending window struts together forming an axially extending frame portion that defines the axial side of each of two adjacent units.

[0319] Example 94. Any example in this document, particularly Example 93, of a prosthetic heart valve, wherein a superior axial strut and two axially extending window struts each extend in an axial direction, wherein the upper edge of the connecting window extends perpendicular to the superior axial strut, and wherein the circumferential direction is relative to the circumference of the frame.

[0320] Example 95. Any example in this document, particularly Example 93 or 94, of a prosthetic heart valve, wherein the upper edge is spaced from the outflow end of the frame by an upper axial strut.

[0321] Example 96. Any example in this article, particularly the prosthetic heart valve of Example 95, wherein the length of the upper axial strut is selected such that the axial distance between the outflow end of the frame and the outflow edge of the multiple leaflets is in the range of 2-3 mm.

[0322] Example 97. Any of the examples in this document, particularly any one of Examples 93-96, is a prosthetic heart valve in which an upper axial strut is arranged between an upper strut joint and an upper edge, the upper strut joint forming a joint between two angled struts arranged at the outflow end of the frame, each of the two angled struts at least partially forming the upper side of a corresponding one of the two adjacent units.

[0323] Example 98. Any of the examples in this document, particularly any one of Examples 93-97, is a prosthetic heart valve, wherein each synaptic window is open at its lower end and wherein each of the two axially extending window struts includes a lower clamping portion, wherein the lower clamping portions of the two axially extending window struts are angled toward each other and define an opening therebetween, the opening being the lower opening of the synaptic window.

[0324] Example 99. Any example in this document, particularly Example 98, is a prosthetic heart valve in which an outwardly curved portion in the lower clamping portion of two axially extending windows forms a neck region configured to receive fasteners.

[0325] Given the many possible implementations to which the principles of the disclosed technology can be applied, it should be understood that the exemplified implementations are merely preferred examples of the disclosed technology and should not be considered as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Claims

1. Prosthetic heart valves, including: A ring-shaped frame, comprising: The frame defines a plurality of interconnected support columns for a multi-row unit, the multi-row being arranged between the outflow end and the inflow end of the frame and including an upper row unit arranged at the outflow end and a lower row unit arranged at the inflow end. Multiple connecting windows are formed between the axially extending window pillars of the frame. Each connecting window is arranged between the axially extending window pillars of two adjacent units in the upper row of units. Each connecting window has an upper region located near the outlet end of the frame and a lower connecting receiving region spaced apart from the upper ends of the two adjacent units. The upper end is located at the outlet end of the frame. Each connecting window has an open end. A connecting window fastener comprising two opposing ends and a middle portion extending between the two ends, wherein the width of the two ends is greater than the width of the middle portion; and The leaflet assembly includes a plurality of leaflets, each leaflet including opposing connecting lugs on opposite sides of the leaflet, each connecting lug pairing with an adjacent connecting lug of an adjacent leaflet to form a connecting portion, wherein each connecting portion is arranged in a lower connecting portion receiving area of ​​a corresponding connecting portion window to hold the leaflet of the prosthetic heart valve in a certain position within the frame, the position maintaining a unit area with opposing openings near the outflow end of the frame within the upper unit, the unit area with opposing openings being sufficient to allow blood flow to the coronary ostium and the passage of a coronary re-entry device after the prosthetic heart valve is implanted, and wherein the open end of the connecting portion window is configured to receive the connecting portion passing through it; Each of the upper window support portions of the connecting window includes a recessed portion that creates a narrowing portion of the corresponding upper window support portion, wherein the recessed portion is shaped to receive the connecting window fastener; and The connecting window fastener is configured such that after the connecting part slides into the opening of the connecting window through the opening end, the middle portion of the connecting window fastener slides from the opening end of the connecting window and slides into the connecting window, wherein the middle portion of the connecting window fastener is arranged between the window pillars, and the ends of the connecting window fastener are respectively positioned radially outward and radially inward of the frame.

2. The prosthetic heart valve of claim 1, wherein the opening end of each commissural window is formed by the upper or lower ends of the axially extending window struts that are spaced apart from each other in the circumferential direction and are not directly connected to each other, the circumferential direction being relative to the circumference of the frame and arranged to be tangent to the axial direction.

3. The prosthetic heart valve according to claim 1 or claim 2, wherein each fusion window is formed between a first axially extending window strut of a first unit and a second axially extending window strut of a second unit in the two adjacent units, the first axially extending window strut and the second axially extending window strut are spaced apart from each other at their upper ends and along their length and are connected together at their lower ends by a transverse window strut portion, wherein each of the first axially extending window strut and the second axially extending window strut includes a lower window strut portion and an upper window strut portion, and wherein the lower fusion receiving region of the fusion is formed in the space between the lower window strut portion of the first axially extending window strut and the lower window strut portion of the second axially extending window strut. The connecting window fastener is configured such that after the connecting part slides into the opening of the connecting window through the opening end, the middle portion of the connecting window fastener slides from the opening end of the connecting window and slides downward into the upper region of the connecting window, wherein the middle portion of the connecting window fastener is arranged between the upper window support portions, and the ends of the connecting window fastener are respectively positioned radially outward and radially inward of the frame.

4. The prosthetic heart valve according to claim 1 or claim 2, wherein each fusion window is formed between a first axially extending window strut and a second axially extending window strut, the first axially extending window strut and the second axially extending window strut are spaced apart from each other at their lower ends and along their length in the circumferential direction, the lower end of each of the first axially extending window strut and the second axially extending window strut is connected to a corresponding lower angled strut of one of the two adjacent units, wherein the first axially extending window strut and the second axially extending window strut are connected together and connected at their upper ends to an upper axial strut via the upper edge of the fusion window extending in the circumferential direction, and wherein the upper axial strut is connected at its upper end to an upper strut joint forming a joint between the upper angled struts of the two adjacent units.

5. The prosthetic heart valve according to claim 1 or claim 2, wherein the annular frame is radially expandable to an expandable configuration.

6. Prosthetic heart valves, including: A ring frame comprising a plurality of interconnected pillars defining multiple rows of units arranged between an outflow end and an inflow end of the frame and including an upper row of units arranged at the outflow end. and Multiple leaflets located within the frame, each leaflet including opposing connecting lugs on opposite sides of the leaflet, each connecting lug pairing with an adjacent connecting lug of an adjacent leaflet to form a connecting portion; The struts defining the upper unit also define fusion windows forming a plurality of openings between adjacent units in the upper unit. Each fusion window is configured to receive a fusion portion therein and is formed by two axially extending window struts spaced apart from each other in a circumferential direction. The fusion windows are axially offset toward the inflow end of the upper unit to hold the leaflets of the prosthetic heart valve in a certain position within the frame. This position maintains a unit region within the upper unit near the outflow end of the frame with opposing openings. The unit regions with opposing openings are sufficient to allow blood flow to the coronary ostium and the passage of the coronary re-entry device after the prosthetic heart valve is implanted. The two axially extending window pillars are connected to the upper axial pillar via the upper edge of the connecting window, and to the lower angled pillar of the upper unit. The upper axial pillar and the two axially extending window pillars together form an axially extending frame portion, which defines the axial side of each of the two adjacent units; and Each of the connecting window portions is open at its lower end, and each of the two axially extending window pillars includes a lower clamping portion, wherein the lower clamping portions of the two axially extending window pillars are angled toward each other and define an opening therebetween, the opening being the lower opening of the connecting window portion.

7. The prosthetic heart valve of claim 6, wherein the upper axial strut and the two axially extending window struts each extend along the axial direction, wherein the upper edge of the connecting window extends perpendicular to the upper axial strut, and wherein the circumferential direction is relative to the circumference of the frame.

8. The prosthetic heart valve according to claim 6 or claim 7, wherein the upper edge is spaced from the outflow end of the frame by the upper axial strut.

9. The prosthetic heart valve of claim 8, wherein the length of the upper axial strut is selected such that the axial distance between the outflow end of the frame and the outflow edge of the plurality of leaflets is in the range of 2-3 mm.

10. The prosthetic heart valve according to claim 6 or claim 7, wherein the upper axial strut is disposed between the upper strut joint and the upper edge, the upper strut joint forming a joint between two angled struts disposed at the outflow end of the frame, each of the two angled struts at least partially forming the upper side of a corresponding one of the two adjacent units.

11. The prosthetic heart valve of claim 6, wherein the outwardly curved portion of the lower clamping portion of the two axially extending windows forms a neck region configured to receive a fastener.

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