Prosthetic valve with crosspieces supporting members

Abstract

A prosthetic valve has a radially expandable annular frame and a leaflet structure positioned within the frame. The frame has an inflow end, an outflow end, a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts; and a plurality of axial frame members including respective first and second ends. The first end is connected to the second row of angled struts and the second end is connected to the third row of angled struts. The plurality of axial frame members includes a plurality of axially extending commissure supports and one or more axial posts located between any two immediately adjacent commissure supports. Each commissure support is configured to support a corresponding commissure of the leaflet structure.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 343,986, filed on May 19, 2022, and U.S. Provisional Application No. 63 / 422,349, filed on November 3, 2022, both of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to implantable, radially expandable prosthetic devices, such as prosthetic heart valves, and to methods, assemblies and apparatus for delivering, expanding, implanting and deploying such prosthetic heart valves. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart, and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve (or simply "prosthetic valve") can be mounted on the distal end of a delivery device in a curled state, and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. Then, for example, by expanding a balloon on which a prosthetic valve is mounted, a mechanical actuator that actuates an expansion force to the prosthetic valve is applied, or by expanding the prosthetic valve from the sheath of the delivery device so that the prosthetic valve can be self-expanded to its functional size to expand the prosthetic valve to its functional size.

[0005] The prosthetic valve may include a radially compressible and radially expandable frame and a leaflet structure mounted within the frame. In some cases, the prosthetic valve may have a sealing member, such as an outer skirt mounted on an outer surface of the frame. The outer skirt may be configured to seal against surrounding natural tissue to reduce paravalvular leakage through the prosthetic valve.

[0006] Despite recent advances in percutaneous valve technology, there remains a need for improved transcatheter prosthetic valves, for example to improve frame strength and / or reduce paravalvular leak. Summary of the invention

[0007] The present disclosure relates to methods and devices for treating valvular disease. In particular, the present disclosure is directed to implantable, radially expandable prosthetic devices, such as prosthetic heart valves, and to methods, assemblies, and apparatus for delivering, expanding, implanting, and deploying such prosthetic devices.

[0008] The prosthetic valve may include a frame and a valve structure coupled to the frame.In addition to these components, the prosthetic heart valve may further include one or more of the components disclosed herein.

[0009] In some instances, a frame of a prosthetic valve can include an inflow end, an outflow end, a first row of angled struts defining the outflow end, a second row of angled struts closer to the inflow end than the first row of angled struts, and a plurality of axial frame members bridging the first row of angled struts and the second row of angled struts.

[0010] In some examples, the frame of the prosthetic valve can include a plurality of support members connecting the plurality of axial frame members.

[0011] In some examples, the support member can be narrower than the axial frame member and the first and second rows of angled struts.

[0012] In some examples, the frame of the prosthetic valve can include a plurality of axial frame members including respective first and second ends, the first ends connected to the first row of angled struts and the second ends connected to the second row of angled struts.

[0013] In some examples, a frame of a prosthetic valve can include a plurality of support members connecting the plurality of axial frame members at a connection point between the first and second ends of the axial frame members.

[0014] In some examples, the prosthetic valve can include an outer skirt disposed on an outer surface of the frame.

[0015] In some examples, the outer skirt can be connected to a support member.

[0016] In some instances, the frame of a prosthetic valve can include a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts, and a plurality of axial frame members including respective first and second ends, the first end connected to the second row of angled struts, and the second end connected to the third row of angled struts.

[0017] In some instances, the plurality of axial frame members can include a plurality of axially extending commissure supports and one or more axial posts between any two adjacent commissure supports, each commissure support being configured to support a corresponding commissure of a leaflet structure, such as a prosthetic valve.

[0018] In some examples, the frame of the prosthetic valve can further include a fourth row of angled struts located upstream of the third row of angled struts.

[0019] In some instances, the first row of angled struts and the second row of angled struts define a plurality of first units of the frame; the second row of angled struts, the third row of angled struts, and the plurality of axial frame members define a plurality of second units of the frame; and the third row of angled struts and the fourth row of angled struts define a plurality of third units of the frame.

[0020] In some examples, the number of first cells is greater than the number of second cells, and the number of second cells is equal to the number of third cells.

[0021] In some examples, when the frame is in the radially expanded configuration, the first cell is smaller than the third cell, and the third cell is smaller than the second cell.

[0022] Certain aspects of the present disclosure relate to a prosthetic valve. The prosthetic valve may include an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, and an outer skirt that is disposed on an outer surface of the annular frame. The annular frame may include an inflow end, an outflow end, a first row of angled struts defining the outflow end, a second row of angled struts that is closer to the inflow end than the first row of angled struts, a plurality of axial frame members bridging the first row of angled struts and the second row of angled struts, and a plurality of support members connecting the plurality of axial frame members. The support member may be narrower than the axial frame member and the first row of angled struts and the second row of angled struts. The outer skirt may be connected to the support member.

[0023] According to certain aspects of the present disclosure, a prosthetic valve may include a radially expandable and radially compressible annular frame, and an outer skirt disposed on an outer surface of the annular frame. The annular frame may include: an inflow end; an outflow end; a first row of angled struts and a second row of angled struts, the first row of angled struts defining the outflow end, the second row of angled struts being located upstream of the first row of angled struts; a plurality of axial frame members, the plurality of axial frame members including respective first and second ends, the first end being connected to the first row of angled struts, and the second end being connected to the second row of angled struts; and a plurality of support members, the plurality of support members connecting the plurality of axial frame members at a connection point located between the first end and the second end. The outer skirt may be connected to the support member.

[0024] Certain aspects of the present disclosure also relate to a radially expandable and radially compressible annular frame. The annular frame may include an inflow end, an outflow end, an outflow strut row defining the outflow end, an inflow strut row defining the inflow end, an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row, a plurality of axial frame members, the plurality of axial frame members including a corresponding first end and a second end, the first end being connected to the outflow strut row, and the second end being connected to the interconnected strut row, and a plurality of support members, the plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row. Each outflow strut may include two angled strut portions interconnected by a vertex portion. The support member may be narrower than the axial frame member, the angled strut portion of the outflow strut, and the interconnected strut row.

[0025] According to certain aspects of the present disclosure, a radially expandable and radially compressible annular frame may include a first end column row defining a first end of the annular frame; a second end column row defining a second end of the annular frame; a plurality of interconnected columns arranged in one or more rows extending circumferentially between the first end column row and the second end column row; a plurality of axial frame members including respective first and second ends, the first end connected to the first end column row and the second end connected to the first row of interconnected columns, and a plurality of support members connecting the plurality of axial frame members at a connection point axially located between the first end and the second end.

[0026] Certain aspects of the present disclosure also relate to an assembly. The assembly may include a prosthetic device having a frame and a delivery device, the prosthetic device being movable between a radially expanded state and a radially compressed state, the delivery device being configured to deliver the prosthetic device in a radially compressed state to a target location. The frame may include an outflow strut row defining an outflow end of the frame, an inflow strut row defining an inflow end of the frame, an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row, a plurality of axial frame members, the plurality of axial frame members including respective first and second ends, the first end being connected to the outflow strut row, and the second end being connected to the interconnected strut row, and a plurality of support members, the plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row. Each outflow strut may include two angled strut portions interconnected by a vertex portion. The support member may be narrower than the axial frame member, the angled strut portion of the outflow strut, and the interconnected strut row.

[0027] Certain aspects of the present disclosure relate to a method for assembling a prosthetic device. The method may include preparing an annular frame, the annular frame including an outflow strut row defining an outflow end of the annular frame, an inflow strut row defining an inflow end of the annular frame, an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row, and a plurality of axial frame members, the plurality of axial frame members having respective first and second ends, the first ends being connected to the outflow strut row, and the second ends being connected to the interconnected strut row. The method may also include bridging the plurality of axial frame members and a plurality of support members such that the support members extend circumferentially between the outflow strut row and the interconnected strut row. Each outflow strut may include two angled strut portions interconnected by an apex portion. The support member may be narrower than the axial frame members, the angled strut portions of the outflow strut, and the interconnected strut row.

[0028] According to certain aspects of the present disclosure, a method of assembling a prosthetic device may include preparing an annular frame, the annular frame including an outflow strut row defining an outflow end of the annular frame, an inflow strut row defining an inflow end of the annular frame, an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row, a plurality of axial frame members, the plurality of axial frame members including respective first and second ends, the first ends connected to the outflow strut row and the second ends connected to the interconnected strut row, and a plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row. The method may also include attaching an outflow skirt to an outer surface of the annular frame. The attaching may include attaching an outflow edge portion of the outer skirt to the plurality of support members. Each outflow strut may include two angled strut portions interconnected by an apex portion. The support member may be narrower than the axial frame members, the angled strut portions of the outflow struts, and the interconnected strut rows.

[0029] Certain aspects of the present disclosure also relate to a method comprising delivering a prosthetic device in a radially compressed state to a target location and radially expanding the prosthetic device to a radially expanded state. The prosthetic device may include a radially expandable and radially compressible frame. The frame may include an outflow strut row defining an outflow end of the frame, an inflow strut row defining an inflow end of the frame, an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row, a plurality of axial frame members, the plurality of axial frame members including respective first and second ends, the first end being connected to the outflow strut row, and the second end being connected to the interconnected strut row, and a plurality of support members, the plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row. Each outflow strut may include two angled strut portions interconnected by a vertex portion. The support member may be narrower than the axial frame member, the angled strut portion of the outflow strut, and the interconnected strut row.

[0030] The above methods may be performed on a live animal or on a simulated object, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (eg, having simulated body parts, hearts, tissues, etc.).

[0031] In some aspects, the prosthetic valve may include an annular frame that is movable between a radially compressed configuration and a radially expanded configuration. The frame has an inflow end and an outflow end. The prosthetic valve may also include a leaflet structure positioned within the frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end. The frame may include a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts, and a plurality of axial frame members, the plurality of axial frame members comprising corresponding first and second ends. The first end may be connected to the second row of angled struts, and the second end may be connected to the third row of angled struts. The plurality of axial frame members may include a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports. Each commissure support may be configured to support a corresponding commissure of the leaflet structure.

[0032] In some aspects, the prosthetic valve may include an annular frame that is movable between a radially compressed configuration and a radially expanded configuration. The frame has an inflow end and an outflow end. The prosthetic valve may also include a leaflet structure positioned within the frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end. The frame may include a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts, a fourth row of angled struts upstream of the third row of angled struts, and a plurality of axial frame members, the plurality of axial frame members comprising respective first and second ends. The first end may be connected to the second row of angled struts, and the second end may be connected to the third row of angled struts. The first row of angled struts and the second row of angled struts may define a plurality of first cells of the frame. The second row of angled struts, the third row of angled struts, and the plurality of axial frame members may define a plurality of second cells of the frame. The third row of angled struts and the fourth row of angled struts may define a plurality of third cells of the frame. The number of first cells may be greater than the number of second cells. The number of second cells may be equal to the number of third cells.

[0033] In certain aspects, an annular frame movable between a radially compressed configuration and a radially expanded configuration may include a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts, a fourth row of angled struts upstream of the third row of angled struts, and a plurality of axial frame members, the plurality of axial frame members comprising respective first and second ends. The first end may be connected to the second row of angled struts, and the second end may be connected to the third row of angled struts. The first row of angled struts and the second row of angled struts may define a plurality of first cells of the frame. The second row of angled struts, the third row of angled struts, and the plurality of axial frame members may define a plurality of second cells of the frame. The third row of angled struts and the fourth row of angled struts may define a plurality of third cells of the frame. When the frame is in the radially expanded configuration, the first cell may be smaller than the third cell, and the third cell may be smaller than the second cell.

[0034] In some aspects, the prosthetic valve may include a radially expandable and radially compressible annular frame. The annular frame may include an outflow strut row defining an outflow end of the frame, an inflow strut row defining an inflow end of the frame, an intermediate row of angled struts axially located between the outflow strut row and the inflow strut row, a plurality of axial frame members bridging the outflow strut row and the intermediate row of angled struts, and a plurality of support structures connecting the plurality of axial frame members and the intermediate row of angled struts. Each support structure may include at least two angled support arms connecting two adjacent axial frame members and at least one axial support member bridging the at least two angled support arms and the intermediate row of angled struts.

[0035] In some aspects, the prosthetic valve may include a radially expandable and radially compressible annular frame. The annular frame may include an outflow strut row defining an outflow end of the frame, an inflow strut row defining an inflow end of the frame, a first intermediate row of angled struts and a second intermediate row of angled struts axially located between the outflow strut row and the inflow strut row, a plurality of axial frame members bridging the outflow strut row and the first intermediate row of angled struts, and a plurality of support structures connecting the plurality of axial frame members and the first intermediate row of angled struts and the second intermediate row of angled struts. The second intermediate row of angled struts is located upstream of the first intermediate row of angled struts. Each support structure may include at least two angled support arms connecting two adjacent axial frame members and two or more axial support members bridging the at least two angled support arms and the first intermediate row of angled struts and the second intermediate row of angled struts.

[0036] In some examples, a prosthetic valve or a frame of a prosthetic valve may include one or more of the components referenced in Examples 1-95 and 107-187 described in the following section "Additional Examples of the Disclosed Technology."

[0037] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 is a perspective view of a prosthetic valve according to one example.

[0039] Figure 2 is a perspective view of a prosthetic valve according to another example.

[0040] Figure 3 is a perspective view of a prosthetic valve according to yet another example.

[0041] Figure 4A is a perspective view of an annular frame of a prosthetic valve according to one example, wherein the annular frame is in an expanded configuration.

[0042] Figure 4B yes Figure 4A Plan view of the expansion frame.

[0043] Figure 4C yes Figure 4A A plan view of a portion of a frame wherein the frame is in a compressed configuration.

[0044] Figure 4D Based on an example Figure 4A A plan view of a portion of the extended frame.

[0045] Figure 5A is a perspective view of an annular frame of a prosthetic valve according to another example, wherein the annular frame is in an expanded configuration.

[0046] Figure 5B yes Figure 5A Plan view of the expansion frame.

[0047] Figure 5C yes Figure 5A A plan view of a portion of a frame wherein the frame is in a compressed configuration.

[0048] Fig. 6A Depicted is an outflow strut of a framework comprising two angled strut portions connected by a U-shaped bend according to one example.

[0049] Figure 6B Depicted is an inflow strut of a framework configuration comprising two angled strut portions connected by a U-shaped bend according to one example.

[0050] Fig. 7A Depicted is a column of a framework according to an example.

[0051] Figure 7B Depicted is a column of a framework according to another example.

[0052] Figure 7C A column of a framework according to yet another example is depicted.

[0053] Fig. 8A Depicted is a plan view of a portion of a ring frame in an expanded configuration according to another example.

[0054] Figure 8B Depicted is a plan view of a portion of a ring frame in an expanded configuration according to another example.

[0055] Fig.9A Depicted is a plan view of a portion of a ring frame in an expanded configuration according to another example.

[0056] Fig. 9B Depicted is a plan view of a portion of a ring frame in an expanded configuration according to another example.

[0057] Fig.10 is a perspective view of a frame of a prosthetic valve according to another example.

[0058] Fig. 10A yes Fig.10 A plan view of a portion of a frame, the frame being in an expanded configuration.

[0059] Fig. 10B yes Fig.10 A plan view of a portion of a frame, the frame being in a compressed configuration.

[0060] Fig.11 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0061] Fig.12 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0062] Fig.13 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0063] Fig.14 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0064] Fig.15 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0065] Fig.16 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0066] Fig.17 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0067] Fig.18 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0068] Fig.19 is a plan view of a portion of a frame for a prosthetic valve according to another example.

[0069] Fig. 20is a side view of a delivery device configured to deliver and implant a prosthetic valve to a target implantation site according to one example. DETAILED DESCRIPTION

[0070] General considerations

[0071] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0072] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this manner of description encompasses repetitions unless the specific language set forth below requires a particular order. For example, in some cases, the operations described in sequence may be repeated or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by a person of ordinary skill in the art.

[0073] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "include" means "comprise". Furthermore, the term "coupled" generally means physical, mechanical, chemical, magnetic, and / or electrical coupling or connection, and does not exclude the presence of intervening elements between the coupled or associated items in the absence of specific language to the contrary. Furthermore, as used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0074] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and further away from an implantation site. Therefore, for example, the proximal motion of a device is a motion of the device away from an implantation site and toward a user (e.g., leaving the patient's body), while the distal motion of the device is a motion of the device away from a user and toward an implantation site (e.g., entering the patient's body). Unless otherwise clearly defined, the terms "longitudinal" and "axial" refer to an axis extending in a proximal and distal direction.

[0075] Direction and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "bottom," "interior," "exterior," etc. may be used. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used to provide some clarity of description where applicable. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, an "upper" portion may become a "lower" portion simply by flipping the object over. Nevertheless, the object is still the same portion and the object remains unchanged.

[0076] General Overview of Prosthetic Valves

[0077] The prosthetic valve disclosed herein can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be curled on an implant delivery device or held by an implant delivery device in a radially compressed state while being advanced through the patient's vascular system on the delivery device. Once the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It should be understood that the prosthetic valve disclosed herein can be used with a variety of implant delivery devices and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0078] According to certain examples, any of the prosthetic valves disclosed herein may be suitable for implantation into a natural aortic valve annulus. In other examples, any of the prosthetic valves disclosed herein may be suitable for implantation into other natural valve annuli of the heart (e.g., the pulmonary valve, mitral valve, and tricuspid valve). In certain examples, the disclosed prosthetic valves may also be implanted into a blood vessel connected to the heart, including the patient's pulmonary artery (for replacing the function of a diseased pulmonary valve) or the superior vena cava or inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and blood vessels. In addition, the disclosed prosthetic valves may also be implanted into a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0079] In some instances, the disclosed prosthetic valve can be implanted into a docking or anchoring device implanted into a natural heart valve or blood vessel. For example, in one instance, the disclosed prosthetic valve can be implanted into a docking device implanted into the pulmonary artery for replacing the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another instance, the disclosed prosthetic valve can be implanted into a docking device implanted into or at a natural mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another instance, the disclosed prosthetic valve can be implanted into a docking device implanted into the superior vena cava or the inferior vena cava for replacing the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0080] Exemplary Components of a Prosthetic Valve

[0081] Figure 1 An exemplary prosthetic valve 10 is shown that can be delivered via a delivery device such as Fig.10 The exemplary delivery device shown in FIG. 1 is advanced through the vasculature of a patient, such as to a native heart valve.

[0082] As shown, prosthetic valve 10 includes a stent or frame 12, a valve structure 14, an inner skirt 16, and a paravalvular outer sealing member or outer skirt 18. Frame 12 may be similar to or replace any of the frames described herein.

[0083] The frame 12 may have an inflow end 15, an outflow end 19, and an intermediate portion 17 between the inflow end 15 and the outflow end 19. The valve structure 14 may be configured to allow one-way flow of fluid through the prosthetic valve 10. In some instances, the valve structure 14 may include a plurality of leaflets 40 that together form a leaflet structure configured to allow blood to flow from the inflow end 15 to the outflow end 19 and to block blood flow from the outflow end 19 to the inflow end 15.

[0084] For example, the valve structure 14 can include three leaflets 40, which can be arranged to collapse in a tricuspid valve arrangement. In other instances, there can be a greater or lesser number of leaflets (e.g., one leaflet, two leaflets, or more than three leaflets). The leaflets 40 can be secured to one another at their adjacent sides to form the commissures 22 (or "commissure tabs") of the leaflet structure 14. The lower (or inflow) edge of the valve structure 14 can define an undulating curved fan shape, and can therefore be referred to as a "fan line." In some instances, the leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0085] Additional examples of leaflet assemblies and methods for attaching leaflets to a frame are described in U.S. Provisional Patent Application No. 63 / 300,302, filed on January 18, 2022, and U.S. Provisional Patent Application No. 63 / 278,922, filed on November 12, 2021, which are incorporated herein by reference.

[0086] The frame 12 may be radially compressible (radially collapsible) and radially expandable (e.g., the radially expanded configuration is shown in FIG. Figure 1 The frame 12 may include a plurality of interconnected angled struts 24. A plurality of circumferentially spaced vertices 26 may be formed at the inflow end 15 and the outflow end 19 of the frame 12. Figure 1 In the embodiment of the present invention, only the apex 26 at the outflow end 19 is visible, while the apex 26 at the inflow end 15 is covered by the outer skirt 18. Each apex 26 may be formed at the junction between two angled struts 24 at the inflow end 15 or the outflow end 19. Figure 1 An example frame design is depicted in which each vertex 26 forms a U-shaped bend between two angled struts 24. In some examples, the angle 30 between two angled struts 24 connected at a vertex 26 can range from 90 to 120 degrees when the frame 12 is in the radially expanded configuration.

[0087] The frame 12 can be formed with a plurality of circumferentially spaced commissure windows 20 adapted to mount the commissures 22 of the valve structure 14 to the frame 12. For example, the frame 12 can include a plurality of axial frame members 28 bridging two adjacent rows of angled struts 24 closest to the outflow end 19. The commissure windows 20 can be formed as through-thickness openings (e.g., axially extending slots) located on selected axial frame members 28. The commissures 22 can be inserted through the commissure windows 20 and secured to the selected axial frame members 28. Therefore, the selected axial frame members 28 having the commissure windows 20 can also be referred to as commissure supports.

[0088] The inner skirt 16 (and any inner skirt described herein) and the outer skirt 18 (and any other outer skirt described herein) can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including fabrics (e.g., polyethylene terephthalate fabrics) or natural tissues (e.g., pericardial tissue). The inner skirt 16 can be disposed on and / or coupled to the inner surface of the frame 12, while the outer skirt 18 can be disposed on and / or coupled to the outer surface of the frame 12. The outer skirt 18 can serve as a sealing member for the prosthetic valve 10 by sealing against tissue of the natural valve annulus and helping to reduce paravalvular leakage through the prosthetic valve 10. The inner skirt 16 can serve as a sealing member to prevent or reduce paravalvular leakage, anchor the leaflets 40 to the frame 12, and / or protect the leaflets 40 from damage caused by contact with the frame 12 during crimping and during the working cycle of the prosthetic valve 10. In some examples, the inflow edge of the leaflet 40 can be sutured to the inner skirt 16 generally along the scallop line. The inner skirt 16 can in turn be sutured to the adjacent angled struts 24 of the frame 12. In other examples, the leaflet 40 can be sutured directly to the frame 12 along the scallop line via sutures.

[0089] Figure 2 Another exemplary prosthetic valve 100 is depicted that includes a radially expandable and / or radially compressible annular frame 102, a valve structure including a plurality of leaflets 104 mounted within the frame 102, and an outer skirt 106 secured to and surrounding an outer surface 134 of the frame 102. The frame 102 can be similar to or replace any of the frames described herein.

[0090] The frame 102 may include a plurality of angled struts 114 and a plurality of vertices (e.g., outflow vertices 108 and inflow vertices 138) spaced circumferentially around the outflow end 118 and the inflow end 116 of the frame 102. Each vertex 108 or 138 is formed at a junction between two angled struts 114 at the inflow end 118 or the outflow end 116.

[0091] Each vertex 108 or 138 may have a Figure 1 The U-shaped apex 26 of the frame 102 may be more rounded or flatter (e.g., less pointed). For example, each vertex 108 (or 138) may include a curved or relatively flat outer surface 107 and an arcuate or curved inner recess 109 ( FIG. 6 ) disposed opposite the outer surface 107. The inner recess 109 may form a thinned region at the vertex 108 (or 138) having a width 113 that is less than or narrower than the width 119 of the angled struts 114. This thinned region of the vertex 108 (or 138) may disperse the stress experienced by the frame 102 away from the vertex and across the two angled struts 114 extending from either side of the vertex 108 (or 138).

[0092] As described herein, the "width" of a frame component (e.g., an angled strut or strut portion, an apex or apex portion, an axial frame member, etc.) is measured between relative locations on opposing surfaces of such frame component, the relative locations extending between the radially inward-facing surface and the radially outward-facing surface of the frame component. The width of a frame component can be measured, for example, by flattening the frame on a planar surface (see, e.g., Figure 4B and 5B ) and measuring the width of a cross section (ie, transverse segment) of the frame assembly taken along a minor axis perpendicular to the longitudinal axis of the frame assembly and parallel to the plane of the page.

[0093] The angled struts 114 may be arranged in multiple rows between the inflow end 116 and the outflow end 118. For example, Figure 2 Four rows of angled struts 114 are shown: a first row 111 of angled struts defining an outflow end 118, a second row 121 of angled struts located upstream of the first row 111 of angled struts, a third row 123 of angled struts located upstream of the second row 121 of angled struts, and a fourth row 115 of angled struts defining an inflow end 116. The first row 111 of angled struts may also be referred to as outflow struts, and the fourth row 115 of angled struts may also be referred to as inflow struts. In other examples, the frame 102 may include a different number of rows (e.g., 3 rows, 5 rows, or more) of angled struts. As described herein, if a frame component (e.g., a row of angled struts) is closer to the inflow end 116 (or farther away from the outflow end 118) than a reference object (e.g., another row of angled struts), the frame component is considered to be located upstream of the reference object.

[0094] The frame 102 can include a plurality of axially extending struts, also referred to herein as axial frame members 110, some of which can define commissure windows (similar to 20) therein. Lateral portions of adjacent leaflets 104 can mate together and extend through the commissure windows, thereby forming commissures 112 that are fixed to the frame 102.

[0095] The axial frame members 110 can bridge the first row 111 of angled struts and the second row 121 of angled struts. For example, the upper ends 146 of the axial frame members 110 can be connected to the lower ends of the first row 111 of angled struts, and the lower ends 148 of the axial frame members 110 can be connected to the upper ends of the second row 121 of angled struts.

[0096] The axial frame member 110 with the first row 111 of angled struts and the second row 121 of angled struts can together form a circumferentially extending row of open outflow cells 126 (which can also be referred to as "first cells" or "upper cells"). The first row 111 of angled struts can form an upper edge or outflow edge of the outflow cell, and the second row 121 of angled struts can form a lower edge or inflow edge of the outflow cell 126. Multiple rows of angled struts located upstream of the first row 111 (e.g., rows 121, 123, 115) can be interconnected to form additional rows of open cells. For example, Figure 2 A second row of intermediate cells 125 disposed adjacent to the middle portion 117 of the frame 102 and a third row of inflow cells 127 disposed at the inflow end 116 of the frame 102 are shown. When the frame 102 is radially expanded, the outflow cells 126 may have a hexagonal shape. In some examples, the outflow cells 126 may be more axially elongated and have a larger opening area than the intermediate cells 125 and the inflow cells 127.

[0097] The outer skirt 106 of the prosthetic valve 100 can include an inflow edge portion 120 (or lower edge portion) that is secured to the inflow struts (e.g., the fourth row 115 of angled struts) via one or more fasteners, such as lock stitches 124. The outer skirt 106 can also include an outflow edge portion 122 (or upper edge portion) that is secured (e.g., via sutures 130) to the second row 121 of angled struts that form the lower edge or inflow edge of the outflow unit 126. In some examples, the lower end 148 of the axial frame member 110 can include an orifice 132 through which the suture 130 can extend to secure the outflow edge portion 122 of the outer skirt 106 to the lower end 148 of the axial frame member 110.

[0098] In some cases, such as Figure 2As shown in , the outflow edge portion 122 of the outer skirt 106 can extend along and follow the shape of the angled struts 114 that form the lower edge or inflow edge of the outflow unit 126, thereby allowing the outflow edge portion 122 to be attached (e.g., via sutures 130) following the zigzag pattern of the second row 121 of angled struts. While such a configuration can allow the outflow edge portion 122 of the outer skirt 106 to be tightly attached to the frame 102, it can also allow the outer skirt 106 to have a relatively short secondary axial height 128, which is the height measured along the portion of the outer skirt 106 that extends axially from a non-apex joint near the inflow end 116 (e.g., the joint where the third row 123 of angled struts and the fourth row 115 of angled struts are connected) to the bottom joint of the outflow unit 126, as shown in FIG. Figure 2 as shown in .

[0099] In some cases, it may be desirable to extend the outer skirt beyond the lower or inflow edge of the outflow cell 126, e.g., above the second row 121 of angled struts (or closer to the outflow end 118 than the second row). For example, it may be desirable to extend the outflow edge portion 122 of the outer skirt 106 toward the outflow end 118 (e.g., closer to the mid-height of the outflow cell 126) in order to increase the surface area to improve the seal to reduce paravalvular leak at the implant site.

[0100] Figure 3 1 is a perspective view of another prosthetic valve 150 including a frame 102 and an outer skirt 156 secured to the frame 102. The frame 102 can be similar to or replace any of the frames described herein. The prosthetic valve 150 can include leaflets 104 assembled to the frame 102, such as Figure 2 As shown and described above.

[0101] like Figure 3 As shown in , the outer skirt 156 can extend around the outer surface of the frame 102 from the inflow end 116 (which is covered by the outer skirt 156) toward the outflow end 118 of the frame 102. In some examples, the outer skirt 156 can be fixed to the support of the frame 102 at the inflow end 116 by one or more sutures 164.

[0102] In some examples, the outflow edge portion 152 of the outer skirt 156 can be secured to the lower end 148 of the axial frame member 110 and / or to the upper ends of the second row 121 of angled struts by one or more sutures 166. In some examples, a portion of the sutures 166 can extend through and be secured to the orifice 132 located at the lower end 148 of the axial frame member 110 (the orifice 132 is located at the lower end 148 of the axial frame member 110). Figure 3 It is shown in dotted lines to indicate its position below the outer skirt 156).

[0103] In some examples, the sutures 166 and / or sutures 164 can be in-and-out sutures. In some examples, the sutures 166 can be continuous between adjacent apertures 132 (e.g., extending into and out of the outer skirt 156). In other examples, the sutures 166 can be separate pieces that individually connect the outflow edge portion 152 of the outer skirt 156 to the corresponding axial frame member 110.

[0104] In some instances, such as Figure 3 As shown in FIG, additional sutures 168, which may be configured as lock stitches, may further secure the outer skirt 156 to angled struts of the frame 102 that are positioned and extend between the inflow end 116 and the lower end 148 of a selected axial frame member 110 (e.g., an axial frame member having a commissure window).

[0105] The zigzag pattern of the outflow edge portion 122 of the outer skirt 106 follows the second row 121 of angled struts. Figure 2 100 different prosthetic valves, Figure 3 The prosthetic valve 150 can have a larger outer skirt 156, the outflow edge portion 152 of which can have a substantially uniform height around the circumference of the frame 102 (i.e., having a substantially constant axial distance relative to the inflow end 116). Thus, the outer skirt 156 can cover at least the lower portion of the outflow unit 126.

[0106] To provide further structural support for the outer skirt 156, e.g., to reduce the likelihood that the outflow edge portion 152 of the outer skirt 156 will extend through the outflow unit 126 or hang loosely thereon (e.g., due to the relatively large size of the outflow unit 126), a rung of support members extending between the axial frame members 110 may be added to the frame 102 so that the outflow edge portion 152 of the outer skirt 156 may be further attached to the support members. Examples of frames having operational support members are described further below.

[0107] Additional details about the prosthetic valve and various components of the prosthetic valve, including related delivery devices / catheters / systems, are described in WIPO patent application publication No. WO 2018 / 222799, which is incorporated herein by reference. Additional examples of frames are further described in U.S. Provisional Patent Application No. 63 / 401,538, filed on August 26, 2022, which is also incorporated herein by reference.

[0108] Exemplary frame with crosspieces of support members

[0109] Figures 4A-4D Depicted is a frame 200 that can be incorporated into any of the prosthetic valves described herein (eg, 10, 100, 150). Similarly, frame 200 can be moved between a radially compressed configuration and a radially expanded configuration.

[0110] like Figure 4A As shown in the figure, the frame 200 has an inflow end 216 (also known as the "second end" or "inflow end"), an outflow end 218 (also known as the "first end" or "outflow end"), and a plurality of angled struts 202, which are arranged in a plurality of rows that extend circumferentially between the inflow end 216 and the outflow end 218.

[0111] As in Figure 4B As depicted in , the frame 200 has four rows of angled struts 202: a first row 222 of angled struts defining an outflow end 218, a second row 224 of angled struts upstream of the first row 222, a third row 226 of angled struts upstream of the second row 224, and a fourth row 228 of angled struts upstream of the third row 226 and defining an inflow end 216. The first row 222 of angled struts may also be referred to as "outflow struts" 208 or "first end struts," and the fourth row 228 of angled struts may also be referred to as "inflow struts" 209 or "second end struts." Although in Figures 4A-4D Four rows of angled struts are depicted in FIG. 2 , but it should be understood that in other examples, the frame 200 may have fewer (e.g., three) or more (e.g., five, six, seven, etc.) rows of angled struts 202 located between the inflow end 116 and the outflow end 218.

[0112] In the depicted example, each outflow strut 208 can include two angled strut portions 204 interconnected by an apex portion 205. For example, each apex portion 205 can bend between a pair of two angled strut portions 204 of a corresponding outflow strut 208. In some examples, each apex portion 205 can have an arc length that extends along at least 25% of the total arc length of the corresponding outflow strut 208. Similarly, each inflow strut 209 can include a pair of angled strut portions 206 interconnected by a curved apex portion 207 (see, e.g., FIG. 2 ). Figure 4B and 4D ). In some examples, each vertex portion 207 can have an arc length that extends along at least 25% of the total arc length of the corresponding inflow strut 209. Figure 2 At the vertices 108 and 138 , the apex portions 205 , 207 may be thinner or narrower (eg, have a smaller width) than the corresponding angled strut portions 204 , 206 .

[0113] Similar to Figure 2The apex 108 and 138 of the embodiment of the present invention are more rounded and flattened. Fig. 6A As depicted in FIG. 1 , the apex portion 205 may form a U-shaped bend (similar to Figure 1 26). Similarly, as in Figure 6B As depicted in , the apex portion 207 may form a U-shaped bend between two angled strut portions 206 corresponding to the inflow struts 209 .

[0114] As in Figures 4A-4D , the frame 200 also includes a plurality of axially extending posts or axial frame members 210 that bridge two rows of angled struts 202 (e.g., a first row 222 and a second row 224) closest to the outflow end 218. The axial direction of the frame 200 is indicated by a longitudinal axis 201 extending from the inflow end 216 to the outflow end 218.

[0115] Each axial frame member 210 may have a first end 212 connected to a first row 222 of angled struts and a second end 214 connected to a second row 224 of angled struts. Figure 4B , the first row 222 angled struts can be joined together to form a first set of alternating upper ends (or peaks) 222U located at the outflow apex portion 205 and lower ends (or valleys) 222L located between adjacent lower ends of adjacent strut portions 204. The upper ends 222U can define the outflow end 218, and the lower ends 222L are closer to the inflow end 216 than the upper ends 222U. The second row 224 angled struts can be joined together to form a second set of alternating upper ends (or peaks) 224U and lower ends (or valleys) 224L. The upper ends 224U are closer to the outflow end 218 than the lower ends 224L. As shown, the axial frame members 210 can connect the lower ends 222L of the first row 222 angled struts to the upper ends 224U of the second row 224 angled struts, respectively.

[0116] According to certain examples, selected axial frame members 210 can be configured as commissure supports 232, each of which can support a corresponding commissure of a valve structure (e.g., including leaflets similar to 40 or 104, as described above) mounted within the frame 200. In the depicted example, the frame 200 includes three axially extending commissure supports 232, which are configured to accommodate three commissures formed by three leaflets, respectively. In the illustrated example, each commissure support 232 can include an opening or commissure window 236 having a substantially rectangular shape that is shaped and sized to accommodate the commissures of two adjacent leaflets therethrough. In other examples, the commissure windows 236 can have any of a variety of shapes (e.g., square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, etc.).

[0117] The commissure supports 232 (and therefore the commissure windows 236) may be angularly spaced from one another around the circumference of the frame 200. The spacing between the commissure supports 232 may or may not be uniform.

[0118] In some examples, each commissure window 236 can be axially offset from the first end 212 and the second end 214 of the corresponding commissure support 232. For example, the axial position of the commissure windows 236 can be selected so that when the leaflet is attached to the frame 200 via the commissure windows 236, the free edge portion (e.g., the outflow edge portion) of the leaflet will not protrude from or pass through the outflow end 218 of the frame 200.

[0119] Other axial frame members 210 (ie, non-commissure supports 232), which may also be referred to as axial posts 234, are located between any two immediately adjacent commissure supports 232. For example, the frame 200 may have two axial posts 234 located between each pair of immediately adjacent commissure supports 232.

[0120] although Figures 4A-4B The frame 200 depicted in the drawings has a total of nine axial frame members 210 (including three joint supports 232 and six axial columns 234), but it should be understood that the frame 200 may have more or less than nine axial frame members 210 (e.g., having more or less than three joint supports 232 and / or a different number of axial columns 234).

[0121] The rows of angled struts 202 and axial frame members 210 may form rows of open cells of the frame 200. For example, a first row 222 of angled struts, a second row 224 of angled struts, and the plurality of axial frame members 210 may define a plurality of first cells 230 (also referred to as "outflow cells") of the frame 200. When the frame 200 is in the expanded configuration, the first cells 230 may have a hexagonal shape.

[0122] In some examples, the second row 224 of angled braces and the third row 226 of angled braces can define a plurality of second cells 238 of the frame 200. Similarly, the third row 226 of angled braces and the fourth row 228 of angled braces define a plurality of third cells 240 (also referred to as “inflow cells”) of the frame 200. When the frame 200 is in the expanded configuration, each of the second cells 238 and the third cells 240 can have a quadrilateral shape.

[0123] Generally, the first cell 230 may have a greater axial length (and a larger area) than the second cell 238 and the third cell 240, thereby creating a larger open space or larger opening near the outflow end 218 for blood flow and coronary artery access.

[0124] As described herein, the rows of open cells 230, 238, and 240 may be arranged in columns of the frame 200 defined by the axial frame members 210. For example, Figure 4B The frame 200 depicted in FIG. 2 has nine columns depicted by nine axial frame members 210 , wherein each column is formed by one first unit 230 , one third unit 240 adjacent to the first unit 230 , and two partial second units 238 located between the first unit 230 and the third unit 240 .

[0125] In some instances, the second cells 238 and the third cells 240 have substantially the same size when the frame 200 is in the expanded configuration. In other instances, the size and / or shape of the second cells 238 and the third cells 240 can be different when the frame 200 is in the expanded configuration. For example, when the frame 200 is in the expanded configuration, the second cells 238 can be approximately diamond-shaped (e.g., the angled struts in the second row 224 and the third row 226 defining each second cell 238 can have equal lengths), wherein the third cells 240 can have a non-diamond shape, for example, the angle formed at each vertex portion 207 (i.e., the angle between a pair of angled strut portions 206) can be greater than the relative angle formed between a pair of angled struts in the third row 226.

[0126] As in Figures 4A-4D, the frame 200 can further include a crosspiece of support members 250 connecting the plurality of axial frame members 210 and extending between the first row 222 of angled struts and the second row 224 of angled struts. Some of the support members 250 can be connected between pairs of adjacent axial posts 234. Some of the support members 250 can connect the commissure supports 232 to adjacent axial posts 234. As described herein, the support members 250 can be used to attach an outer skirt (similar to 18, 106, 156) mounted on an outer surface of the frame 200. For example, an outflow edge portion (e.g., 122, 152) of the outer skirt can be connected to the support member 250 via sutures.

[0127] The support members 250 may be configured to be axially foldable. For example, each support member 250 may include two arm portions 252 (hereinafter also referred to as "angled support arms") and a joint portion 254 (e.g., in the form of angled struts) connecting the two arm portions 252, and may be configured to be axially foldable when the frame 200 is extended from a radial configuration (see, e.g., Figure 4A ) moves to a radial compression configuration (see e.g. Figure 4C ), the support member 250 can be folded at the joint portion 254. When folded, the two arm portions 252 of each support member 250 can be configured to be substantially parallel to two adjacent axial frame members 210 and extend between the two adjacent axial frame members.

[0128] exist Figures 4A-4B In the example depicted in FIG. 2 , the joint portion 254 of each support member 250 forms a U-shaped bend between the corresponding pair of arm portions 252 and extends upward (ie, toward the outflow end 218). Figure 4D In another example depicted in , the joint portion 254 of each support member 250 can be curved between the corresponding pair of arm portions 252 (similar to the more rounded or flattened apex portions 205, 207). In some examples, when the frame 200 is radially expanded, the two arm portions 252 can form an obtuse angle (e.g., >90 degrees) at the joint portion 254.

[0129] Each support member 250 can connect two adjacent axial frame members 210. In some examples, the two arm portions 252 of each support member 250 have the same or substantially the same length and are configured to be symmetrical about the corresponding joint portion 254. Figures 4A-4D , each arm portion 252 is substantially straight, except for an end portion 256 opposite the joint portion 254, which may be curved. The end portion 256 is where the support member 250 is connected to the corresponding axial frame member 210. Therefore, the end portion 256 may also be referred to as an attachment portion.

[0130] The support member 250 can be configured to have a smaller width than any other strut component of the frame 200. For example, the support member 250 can be narrower than the axial frame member 210 (including the commissure support 232) and any of the rows (e.g., 222, 224, 226, 228) of angled struts 202. As described herein, when the outflow strut 208 or the inflow strut 209 has a thinned apex portion (e.g., 205, 207), the width of the outflow strut 208 or the inflow strut 209 refers to the width of the corresponding angled strut portion 204, 206. Therefore, as described herein, the support member 250 is narrower than the angled strut portion 204 of the outflow strut 208 and the angled strut portion 206 of the inflow strut 209.

[0131] In some instances, the angled struts 202 in any of the rows (e.g., 222, 224, 226, 228) are narrower than the axial frame member 210. The greater width of the axial frame member 210 allows for a greater contact area when the leaflets contact the wider inner surface of the axial frame member 210 during contraction, thereby distributing stresses and reducing the extent to which the leaflets may fold over the axial frame member 210, radially outward through the first cell 230. Thus, the long-term durability of the leaflets may be increased.

[0132] Increasing the width of the axial frame member 210 can reduce the area of ​​the first cell 230, particularly when the frame 200 is radially compressed. As described herein, the support member 250 is configured to be sufficiently thin or narrow so that when the frame 200 is radially compressed, the folded support member 250 can fit within the narrowed (and elongated) first cell 230 (see, e.g., Figure 4C ). This can be achieved, for example, by forming the support member 250 from a fully annealed metal, such as cobalt chromium, stainless steel, or the like.

[0133] In some examples, the angled struts in the first row 222 (ie, outflow struts 208) and the fourth row 228 (ie, inflow struts 209) can have substantially the same width. The angled struts in the second row 224 and the third row 226 can have substantially the same width.

[0134] In some instances, the angled struts in the second row 224 and the third row 226 are narrower than the angled struts in the first row 222 (ie, outflow struts 208 ) and the fourth row 228 (ie, inflow struts 209 ).

[0135] In some examples, the width of the support member 250 can be between 0.1 mm and 0.3 mm, or within a range including between 0.18 mm and 0.22 mm. In one specific example, the width of the support member 250 is about 0.20 mm.

[0136] In some examples, the width of the angled strut portions 204, 206 of the outflow struts 208 and the inflow struts 209 can range from 0.3 mm to 0.5 mm or 0.38 mm to 0.42 mm, including the end values ​​therein. In a specific example, the width of the angled strut portions 204, 206 is about 0.4 mm.

[0137] In some examples, the width of the apex portions 205, 207 of the outflow struts 208 and the inflow struts 209 can range from 0.15 mm to 0.25 mm or 0.18 mm to 0.22 mm, including the end values ​​therein. In a specific example, the width of the apex portions 205, 207 is about 0.20 mm.

[0138] In some examples, the width of any angled struts 202 other than the outflow struts 208 and the inflow struts 209 (e.g., the angled struts in the second row 224 and the third row 226) can range from 0.15 mm to 0.35 mm or 0.23 mm to 0.27 mm, including the end values ​​therein. In a specific example, the width of any angled struts 202 in the second row 224 and the third row 226 is about 0.25 mm.

[0139] In some instances, the width of the axial frame member 210 can range from 0.2 mm to 2 mm or 0.8 mm to 1.2 mm, inclusive. In some instances, the commissure supports 232 (i.e., the axial frame member having the commissure windows 236) are wider than the axial posts 234. In any instances described herein, if the commissure supports 232 have a variable width along their axial length (e.g., portions of the commissure supports 232 surrounding the commissure windows 236 can be wider than portions of the commissure supports above and / or below the commissure windows), the width of the commissure supports 232 refers to the maximum width along the entire axial length of the commissure supports 232. In some instances, the width of the axial posts 234 can range from 0.3 mm to 1.5 mm or 0.6 mm to 1 mm, inclusive. In some instances, each axial post 234 can have a substantially uniform width between the first end 212 and the second end 214 of the axial post 234. In some instances, each commissure support 232 can have a non-uniform width between the first end 212 and the second end 214 of the commissure support 232. For example, each commissure support 232 can have a middle portion 231 defining a commissure window 236 and two end portions 233 located above and below the commissure window 236, and the middle portion 231 can be wider than the two end portions 231. In a specific instance, the width of the middle portion 231 of the commissure support 232 can range from 1.2 mm to 1.6 mm, including the end values ​​therein (e.g., 1.4 mm). The width of the end portions 233 located above and below the commissure window 236 can range from 1.0 to 1.4 mm, including the end values ​​therein (e.g., 1.2 mm). In some examples, the width of the commissure windows 236 can range from 0.5 mm to 0.7 mm, inclusive (eg, 0.6 mm).

[0140] As described herein, each support member 250 can be connected to two adjacent axial frame members 210 at a corresponding connection point 258, which can be the first end 212, the second end 214, or anywhere between the first end 212 and the second end 214 of the axial frame member 210.

[0141] exist Figures 4A-4DIn the example depicted in , the connection point 258 is located at the second end 214 of the axial frame member 210. The support member 250 can divide the first unit 230 into a corresponding upper unit portion 230U and a lower unit portion 230L, and the upper unit portion 230U is closer to the outflow end 218 than the lower unit portion 230L. In the depicted example, when the frame 200 is in the radially expanded configuration, the upper unit portion 230U is larger than the lower unit portion 230L. In other examples, when the frame 200 is in the radially expanded configuration, the lower unit portion 230L can be larger than the upper unit portion 230U or have approximately the same size as the upper unit portion. In the depicted example, when the frame 200 is in the radially expanded configuration, the lower unit portion 230L has a quadrilateral shape. When the outer skirt (similar to 18, 106, 156) is attached to the support member 250, the lower unit portion 230L can be covered by the outer skirt, and the upper unit portion 230U can provide an opening for coronary artery access.

[0142] exist Figures 4A-4D In the example depicted in FIG, the joint portion 254 of each support member 250 is configured to move axially toward the outflow end 218 (and thus further away from the inflow end 216) when the frame 200 is radially compressed (and thus allows the corresponding arm portion 252 to fold), and to move axially toward the inflow end 216 (and thus further away from the outflow end 218) when the frame 200 is radially expanded (and thus allows the corresponding arm portion 252 to unfold).

[0143] Figures 5A-5C Another radially expandable and radially compressible frame 260 is depicted, which can be incorporated into any of the prosthetic valves described herein (e.g., 10, 100, 150). Similar to 200, the frame 260 includes four rows (e.g., 222, 224, 226, 228) of angled struts 202 and a plurality of axial frame members 210, the axial frame members including three commissure supports 232 with corresponding commissure windows 236 and six axial posts 234 distributed circumferentially between the commissure supports 232. Again, the plurality of rows of angled struts 202 and axial frame members 210 can define a first cell row 230, a second cell row 238, and a third cell row 240.

[0144] The frame 260 also includes a plurality of support members 250 extending between the axial frame members 210. Similarly, each support member 250 includes two arm portions 252 connected by a joint portion 254, and each arm portion 252 is connected to a corresponding axial frame member 210 at a corresponding connection point 258. Figures 5A-5CIn the example depicted in , each arm portion 252 is configured to be substantially straight. Likewise, the support member 250 can be configured to be narrower than the axial frame member 210 and the angled struts 202 in any of the rows (e.g., 222, 224, 226, 228).

[0145] wherein the connection point 258 overlaps the second end 214 of the axial frame member 210 Figures 4A-4D The examples are different. Figures 5A-5C In the example depicted in FIG. 2 , the connection point 258 is located axially between the first end 212 and the second end 214 of the axial frame member. Thus, only the second row 224 of angled struts connect the second ends 214 of the axial frame members 210 .

[0146] like Figures 5A-5C , for support member 250 connected to commissure support 232, a corresponding connection point 258 can be located between first end 212 and commissure window 236, i.e., connection point 258 can be axially spaced from commissure window 236. In other examples, connection point 258 can be located axially along commissure window 236. Commissure support 232 has less material or mass along the portion of support 232 that forms the window. Thus, in some cases, placing connection point 258 away from commissure window 236 can improve the stability of connection point 258 (e.g., reduce the likelihood that the connection point will bend inward and squeeze the commissure tab when frame 260 is expanded).

[0147] In some instances, such as in Figures 5A-5C As depicted in FIG. 1 , the axial column 234 may include an orifice 235 (similar to Figure 3 132), the orifice being configured to allow a suture to extend through so as to secure the outer skirt to the axial column 234. In the depicted example, the orifice 235 is located around the second end 214 of the axial column 234. In other examples, the orifice 235 can be located at a position between the first end 212 and the second end 214 of the axial column 234. In still another example, the orifice 235 can be located around the first end 212 of the axial column 234. In the depicted example, each axial column 234 has an orifice 235. In other examples, some axial columns 234 can have more than one orifice 235 or no orifice 235. In still other examples, some of the commissure supports 232 can also have orifices 235, which can be located above and / or below the commissure windows 236.

[0148] Similarly, the support member 250 may divide the first unit 230 into the upper unit portion 230U and the lower unit portion 230L, respectively. Figure 5BIn the example depicted in FIG, when the frame 260 is in the radially expanded configuration, the upper unit portion 230U is smaller than the lower unit portion 230L. In other examples, when the frame 260 is in the radially expanded configuration, the upper unit portion 230U can be larger than or have substantially the same size as the lower unit portion 230L. In the depicted example, when the frame 260 is in the radially expanded configuration, the upper unit portion 230U has a hexagonal shape and the lower unit portion 230L has an irregular hexagonal shape.

[0149] exist Figures 5A-5C In the example depicted in , the joint portion 254 of each support member 250 extends downward (i.e., toward the inflow end) and is configured to move axially toward the inflow end 216 (thus away from the outflow end 218) when the frame 260 is radially compressed (thus allowing the corresponding arm portion 252 to fold), and to move axially toward the outflow end 218 (thus away from the inflow end 216) when the frame 260 is radially expanded (thus allowing the corresponding arm portion 252 to unfold). Figure 5C As shown in , when folded, the two arm portions 252 of each support member 250 can be configured to extend substantially parallel to and between two adjacent axial frame members 210.

[0150] The connection point 258 may be configured to be located at other locations on the axial frame member 210 .

[0151] As an example, Fig. 7A A column of a frame 270 is shown in which a support member 250 connects the commissure support 232 and the axial column 234. The connection point 258 on the commissure support 232 is located between the second end 214 and the commissure window 236. The connection point 258 on the axial column 234 is located above and adjacent to the second end 214 having the orifice 235. The joint portion 254 of the support member 250 extends upward (toward the outflow end 218). Therefore, when the frame 270 is radially compressed, the joint portion 254 can move toward the outflow end 218 (and away from the inflow end 216), while the two arm portions 252 are folded between the commissure support 232 and the axial column 234.

[0152] As another example, Figure 7B Another column of frames 280 is shown in which the support members 250 connect the commissure supports 232 and the axial posts 234. In this example, the connection points 258 on both the commissure supports 232 and the axial posts 234 are located at approximately the midpoint of the respective first and second ends 212, 214. Figure 7B7A. In the depicted example, the commissure windows 236 are located above the corresponding connection points 258. In other examples, the commissure windows 236 can be located below the corresponding connection points 258. In the depicted example, the joint portion 254 of the support member 250 extends upward and can move toward the outflow end 218 when the frame 280 is radially compressed. In other examples, the joint portion 254 can extend downward and move toward the inflow end 216 when the frame 280 is radially compressed.

[0153] As another example, Figure 7C Another column of a frame 290 is shown in which a support member 250 connects the commissure supports 232 and the axial posts 234. In this example, the connection points 258 on both the commissure supports 232 and the axial posts 234 are located about the respective first ends 212. When the frame 290 is radially compressed, the joint portion 254 of the support member 250 extends toward the inflow end 216 and can move toward the inflow end.

[0154] In some instances, such as Figures 7A-7C , the attachment portion or end portion 256 of each arm portion 252 can have a curved shape, and each arm portion 252 can be connected to the corresponding joint support 232 or axial column 234 via the curved attachment portion 256. The curvature of the attachment portion 256 can be configured to facilitate folding of the support member 250. For example, when the joint portion 254 of the support member 250 is extended upward (see, e.g. Figure 7A-7B ), the corresponding attachment portion 256 can form an arc, the center of which is located below or further upstream of the connection point 258. In contrast, when the joint portion 254 extends downward (see, for example, Figure 7C ), the corresponding attachment portion 256 can form an arc, the center of which is located above or further downstream of the connection point 258.

[0155] It should be understood that Figures 7A-7C The examples depicted in are not exhaustive. In various examples, the connection point 258 can be located at any portion of the axial frame member 210. In various examples, the connection point 258 can be axially spaced or aligned with an opening (e.g., the joint window 236 and / or the orifice 235) on the axial frame member 210. In various examples, the joint portion 254 of the support member 250 can extend toward the inflow end 216 or the outflow end 218. In addition, when the frame is in a radially expanded configuration, the angle formed between the joint portion 254 and the paired corresponding arm portions 252 can also vary, such as 90 degrees to 180 degrees, 100 degrees to 170 degrees, 110 degrees to 160 degrees, 120 degrees to 150 degrees, 130 degrees to 140 degrees, etc.

[0156] Such design variations allow the connection points 258 and / or joint portions 254 to be positioned at different heights relative to the axial frame member 210. This, therefore, allows the outer skirt that can be attached to the support member 250 to cover different areas of the first unit 230.

[0157] In some examples, when the frame is in the radially expanded configuration, the joint portion 254 can be closer to the outflow end 218 than the second end 214 of the axial frame member 210. In some examples, when the frame is in the radially expanded configuration, the joint portion 254 can be axially aligned with the midpoint between the first end 212 and the second end 214.

[0158] In some examples, the connection point 258 can be axially closer to the first end 212 than the midpoint between the first end 212 and the second end 214. In some examples, the midpoint between the first end 212 and the second end 214 can be axially closer to the first end 212 than the connection point 258.

[0159] In some examples, when the frame is in the radially expanded configuration, the joint portion 254 of the support member 250 can be axially closer to the second end 214 than the connection point 258. In some examples, when the frame is in the radially expanded configuration, the joint portion 254 of the support member 250 can be axially closer to the first end 212 than the connection point 258. In one specific example, when the frame is in the radially expanded configuration, the joint portion 254 can be axially aligned with the first end 212 of the axial frame member 210.

[0160] In some examples, when the frame is in the radially expanded configuration, the axial distance H between the inflow end 216 of the frame and the joint portion 254 of the support member 250 (see, e.g., Figure 4B and 5B ) may be at least 10 mm. In some examples, when the frame is in the radially expanded configuration, the axial distance H may be one-third to two-thirds of the frame height (ie, the axial distance measured between the inflow end 216 and the outflow end 218).

[0161] When an outer skirt (similar to 18, 106, 156) is disposed on the outer surface of the frame and an outflow edge portion (e.g., 122, 152) of the outer skirt is connected to the support member 250, the outer skirt can extend from the inflow end 216 of the frame to the support member, thereby covering at least a lower portion (e.g., lower cell portion 230L) of the first cell 230. Because the support member 250 extends across the middle portion of the first cell 230, the support member 250 can provide additional structural support for the outer skirt. In some cases, such additional structural support for the outer skirt can enhance the connection of the outflow edge of the skirt to the frame, and can help reduce the likelihood that portions of the outflow edge portion of the outer skirt will protrude inwardly through the first cell 230 and contact the leaflets 104.

[0162] In some examples, the outflow edge portion of the outer skirt can be axially located between the first end 212 and the second end 214 of the axial frame member 210. In some examples, the outflow edge portion of the outer skirt can be axially closer to the outflow end 218 of the frame than the second end 214 of the axial frame member 210. In one specific example, the outflow edge portion of the outer skirt can be axially aligned with the midpoint between the first end 212 and the second end 214 of the axial frame member 210. In another specific example, the outflow edge portion of the outer skirt can be axially aligned with the first end 212 of the axial frame member 210.

[0163] In order to assemble the prosthetic valve, an annular frame with a crosspiece of a support member as described above can be prepared. In some instances, the frame can be constructed by forming individual components (e.g., angled struts, axial frame members, support members, etc.) and then mechanically assembling and connecting the individual components together. In other instances, the frame can be composed of a single piece of material (e.g., nitinol, stainless steel, cobalt-chromium alloy, etc.), such as in the form of a tube. Multiple units, struts, and support members can be formed by removing portions of a single piece of material (e.g., via laser cutting, electroforming, physical vapor deposition, etc.).

[0164] In some examples, the frame may be initially constructed to include multiple rows of angled struts and axial frame members, and then support members may be added (eg, welded) to connect the axial frame members.

[0165] Once the frame is formed, a valve structure comprising a plurality of leaflets (similar to 40 or 104) can be installed in the frame. In some instances, an inner skirt (similar to 16) can be attached to the inner surface of the frame, and the inner skirt can be configured to be located between the leaflets and the inner surface of the frame. An outer skirt (similar to 18, 106, 156) can be installed on the outer surface of the frame. An inflow edge portion of the outer skirt can be fixed to the inflow struts of the frame, and an outflow edge portion of the outer skirt can be connected to the support member, for example, via sutures. In some cases, the outflow edge portion of the outer skirt can also be connected to at least some of the axial frame members, for example, via sutures.

[0166] Exemplary frame with reinforced outflow end portion

[0167] In some cases, after receiving transcatheter aortic valve replacement surgery, the patient may need to undergo post-implantation surgery that requires open-chest surgery involving a heart-lung machine. During open-chest surgery, an aortic cross-clip is often used to clamp the aorta to separate the systemic circulation from the cardiac outflow. If the aortic cross-clip is placed in a position corresponding to an implanted prosthetic valve, there is a possibility that the aortic cross-clip may deform the prosthetic valve, especially if the valve has a plastically deformable frame.

[0168] As described herein, any of the prosthetic valves described herein (e.g., 10, 100, 150) can be reinforced to have improved pressure resistance to the compressive forces applied by the aortic cross clamp. This can be achieved, for example, by reinforcing the outflow end portion of the frame that is located downstream of the leaflets. It is desirable to limit the reinforcement to the outflow end portion of the frame, because further strengthening other portions of the frame may require inflating the balloon in a manner that applies greater force to expand the frame, which may damage or even tear the leaflets. If the reinforced frame portion is located downstream of the leaflets, this risk can be reduced.

[0169] In some instances, the prosthetic valve can be strengthened by strengthening the outflow struts of the frame, for example, by thickening and / or widening the outflow struts. For example, the width of the first row of struts 111 of the frame 102 can be greater than the other rows (121, 123, 115) of struts. As another example, the width of the first row of struts 222 of the frame 200 can be greater than the other rows (224, 226, 228) of struts. In some cases, increasing the width of the outflow struts by 15% can increase the strength of the outflow struts by about 50%, and increasing the width of the outflow struts by 25% can increase the strength of the outflow struts by about 100%. Additionally and / or alternatively, the outflow struts can be strengthened by using a metal and / or alloy material that is stronger than other parts of the frame.

[0170] In some examples, the outflow end portion of the frame may be strengthened by adding a crosspiece of a support member, similar to Figure 5A-5B and Figure 7C For example, a crosspiece of support members 250 may be added between axial frame members 210, with connection points 258 adjacent to outflow struts 208 (similar to Figure 5A-5B ) or overlaps with the first end 212 of the axial frame member 210 (similar to Figure 7C Thus, as an alternative or in addition to the support arms for attaching the outer skirt, Figure 5A-5B and Figure 7C The crosspiece of the support member 250 depicted in FIG. 2 can also enhance the strength of the outflow end portion of the frame. In some examples, the outflow end portion of the frame can be enhanced by adding Figure 5A-5B and Figure 7C The crosspieces of the support members may be similar to the crosspieces of the support members and / or may be reinforced by thickening and / or widening the outflow struts 208 as described above.

[0171] In some examples, the outflow end portion of the frame can be strengthened by adding one or more optional axial support struts that bridge the crosspieces of the support member and the outflow struts. Figure 4D An axial support strut 225 is depicted (shown in phantom to indicate that it is optional) that connects between the joint portion 254 of the support member 250 and the apex portion 205 of the outflow strut 208. In this case, the axial support strut 225 can further divide the upper unit portion 230U of the first unit 230 into two side-by-side halves. In some instances, the axial support strut 225 can bridge each pair of support members 250 and outflow struts 208 (i.e., each unit portion 230U of the frame includes an axial support strut 225). In other instances, the axial support strut 225 can bridge selected pairs of support members 250 and outflow struts 208 (e.g., each other unit portion 230U can include an axial support strut 225).

[0172] exist Figure 5A-5B and Figure 7C In the example depicted in FIG, the connection point 258 for the crosspiece of the support member 250 is located on the axial frame member 210, so that the crosspiece of the support member 250 is located upstream of the outflow strut 208 and divides the outflow unit 230 into an upper unit portion 230U and a lower unit portion 230L. In other examples, the outflow end portion of the frame can be strengthened by adding a crosspiece of the support member downstream of the outflow strut, as described below.

[0173] Figures 8A-8B9A-9B depict additional examples of frames 200a, 200b, 200c, and 200d, each of which can be incorporated into any of the prosthetic valves described herein (e.g., 10, 100, 150). Similarly, each frame 200a, 200b, 200c, or 200d can be moved between a radially compressed configuration and a radially expanded configuration.

[0174] Fig. 8A The framework 200a depicted in the figure is similar to the framework 200,260,270,280 and 290 described above, except the position of the crosspiece of the support member.As shown in the figure, the framework 200a has a crosspiece connected to the outflow pillar 208 and positioned at the support member 251 downstream of the outflow pillar.Therefore, the outflow end 218' of the framework 200a is limited by the crosspiece of the support member 251 rather than the outflow pillar 208.Specifically, the outflow pillar 208 is joined together at the upper end 208U and the lower end 208L alternately.The upper end 208U is axially located between the lower end 208L and the outflow end 218'.In other words, the lower end 208L is located at the upper end 208U upstream, and the upper end is located at the outflow end 218' upstream.In this example, each axial framework member (comprising the joint support 232 and the axial column 234) in the axial framework member 210 is connected to a lower end in the lower end 208L.

[0175] Figure 8B The frame 200b depicted in FIG. 2 is identical to 200a except that an axial frame member 210 (including commissure supports 232 and axial posts 234) is connected to the upper end 208L.

[0176] When the crosspiece of the support member 251 is located downstream of the outflow struts 208, the crosspiece of the support member 251 can also be considered as a row of angled struts. Therefore, the frame 200a or 200b has at least five rows of angled struts: a first row 221 of angled struts defined by the crosspiece of the support member 251, a second row 222 of angled struts defined by the outflow struts 222, a third row 224 of angled struts located upstream of the second row 222, a fourth row 226 of angled struts located upstream of the third row 224, and a fifth row 228 of angled struts located upstream of the fourth row 226. The rows 222, 224, 226, and 228 correspond to the same numbered rows of 4B, respectively. In the depicted example, the axial frame member 210 (including the commissure supports 232 and the axial posts 234) connects the second row 222 of angled struts and the third row 224 of angled struts, and the fifth row 228 of angled struts defines the inflow end 216. In other examples, the frame 200a or 200b may have more than five rows of angled braces (eg, additional rows of angled braces may be added upstream of the fifth row 228).

[0177] Similarly, the crosspiece of the increased support member 251 can enhance the strength of the outflow end portion of the frame 200a or 200b. In some instances, the outflow end portion of the frame 200a or 200b can be further strengthened by thickening and / or widening the outflow pillar 208 as described above. For example, the angled pillars (outflow pillars 208) of the second row 222 can be wider than the angled pillars of other rows (221, 224, 226 and 228). In some instances, the width of the angled pillars (crosspieces of the support member 251) of the first row 221 can be smaller than the angled pillars of other rows (222, 224, 226 and 228). In some instances, the width of the angled pillars of the first row 221 can be the same as the width of the angled pillars of the second row 222, the third row 224, the fourth row 226 and / or the fifth row 228.

[0178] like Figures 8A-8B As shown in , the frame 200a or 200b can have at least four rows of open cells: the first row 221 angled struts and the second row 222 angled struts can define a plurality of first cells 229; the second row 222 angled struts, the third row 224 angled struts and the plurality of axial frame members 210 can define a plurality of second cells 230; the third row 224 angled struts and the fourth row 226 angled struts can define a plurality of third cells 238; the fourth row 226 angled struts and the fifth row 228 angled struts can define a plurality of fourth cells 240. Cells 230, 238 and 240 correspond to the same numbered cells of 4B, respectively.

[0179] In the depicted example, when the frame 200a or 200b is in the radially expanded configuration, the first cell 229 has a substantially diamond shape. The shapes of the cells 230, 238, and 240 match the same numbered cells of 4B, respectively. When the frame 200a or 200b is in the radially expanded configuration, the second cell 230 has a larger area (and a larger axial length) than the other cells (229, 238, and 240). In this example, the first cell 229 has the same number as the second cell 230, the third cell 238, and the fourth cell 240 (e.g., 9 cells each for 229, 230, 238, and 240).

[0180] In some examples, the outflow end portion of the frame 200a or 200b can be further strengthened by adding one or more axial support struts that bridge the angled struts of the second row 222 and the angled struts of the third row 224. For example, the axial support strut 225 (shown in phantom to indicate that it is optional) can be provided at the joint of two angled struts in the second row 222 (e.g., Fig. 8A 208U or Figure 8BThe second unit 230 is connected and extends between the axially aligned joints of the two angled struts in the third row 224 and the corresponding second unit 230 so that the corresponding second unit 230 can be divided into two side-by-side halves. In some examples, each second unit 230 can include an axial support strut 225. In other examples, selected second units 230 (e.g., every other second unit 230) can include an axial support strut 225.

[0181] Fig.9A The frame 200c depicted in is similar to the frame 200a described above, except for the arrangement of the crosspieces of the outflow struts and the support members. Compared with the frame 200a having two angled outflow struts 208 bridging each pair of adjacent axial frame members 210, the frame 200c has four angled outflow struts 208' extending between each pair of adjacent axial frame members 210. The outflow end 218' of the frame 200c is defined by the crosspiece of the support member 251', which is connected to the outflow strut 208' and is located downstream of the outflow strut. As shown, the outflow strut 208' is joined together at alternating upper ends 208U' and lower ends 208L', and the upper end 208U' is axially located between the lower end 208L' and the outflow end 218'. In the depicted example, the axial frame member 210 (including the joint support 232 and the axial column 234) is connected to every other one in the lower end 208L'.

[0182] Fig. 9B The frame 200d depicted in FIG. 2 is identical to 200c except that each of the axial frame members 210 (including the commissure supports 232 and axial posts 234) is connected to every other one of the upper ends 208U.

[0183] Similarly, frame 200c or 200d has at least five rows of angled struts: a first row 221 formed by the crosspieces of support member 251', a second row 222 formed by outflow struts 208', a third row 224 located upstream of the second row 222, a fourth row 226 located upstream of the third row 224, and a fifth row 228 located upstream of the fourth row 226.

[0184] In this example, the crosspiece of the added support member 251' can enhance the strength of the outflow end portion of the frame 200c or 200d. In some examples, the outflow end portion of the frame 200c or 200c can be further strengthened by thickening and / or widening the outflow pillar 208' as described above. For example, the pillars of the second row 222 angled pillars (outflow pillars 208') can be wider than the angled pillars of other rows (221, 224, 226 and 228). In some examples, the width of the pillars of the first row 221 angled pillars (crosspiece of the support member 251') can be less than the other rows (222, 224, 226 and 228) of the angled pillars. In some examples, the width of the pillars of the first 221 angled pillars can be the same as the width of the pillars of the second row 222, the third row 224, the fourth row 226 and / or the fifth row 228.

[0185] Similarly, frame 200c or 200d has at least four rows of units: a first unit 229' formed by the angled struts in the first row 221 and the angled struts in the second row 222, a second unit 230' formed by the angled struts in the second row 222 and the angled struts in the third row 224 and the axial frame member 210, a third unit 238 formed by the angled struts in the third row 224 and the angled struts in the fourth row 226, and a fourth unit 240 formed by the angled struts in the fourth row 226 and the angled struts in the fifth row 228.

[0186] exist Figures 9A-9B In the example, the third unit 238 and the fourth unit 240 correspond to Figures 8A-8B However, the size, shape and / or number of the first unit 229' and the second unit 230' may be the same Figures 8A-8B For example, although the number of second cells 230' is the same as that of third cells 238 and fourth cells 240, the number of first cells 229' is twice the number of second cells 230'. In one specific example, the number of first cells 229' is 18, and the number of second cells 230' is 9. In addition, when the frame 200c or 200d is in the radially expanded configuration, the first cell 229' has a smaller area (e.g., less than 50%) than the third cell 238 and / or the fourth cell 240.

[0187] It should be understood that Figures 8A-8B The frame configurations shown in 9A-9B are merely exemplary, and the frame may have other configurations based on the principles described herein. For example, the number (N) of angled outflow struts connecting each pair of adjacent axial frame members 210 may be different from 2 (as in 8A-8B) or 4 (as in Figures 9A-9BThe first unit may be a plurality of first units, such as 3, 5, 6, 7, 8, etc. The crosspiece of the support member defining the outflow end of the frame may be connected to these outflow struts and located downstream of the outflow struts, thereby forming a plurality of first units. The ratio (R) between the number of first units and the number of second units may be N:2. For example, if N=3, the ratio R is 3:2, or if N=6, the ratio R is 3:1, etc.

[0188] In some examples, the outflow end portion of frame 200c or 200d can be further strengthened by adding one or more axial support struts that bridge the angled struts of the second row 222 and the angled struts of the third row 224. For example, axial support strut 225 (shown in phantom to indicate that it is optional) can be provided at the joint of two angled struts in the second row 222 (e.g., Fig.9A 208L' or Fig. 9B The second unit 230' is connected and extends between the axially aligned joints of the two angled struts in the third row 224, so that the corresponding second unit 230' can be divided into two side-by-side halves. In some examples, each second unit 230' can include an axial support strut 225. In other examples, selected second units 230' (for example, every other second unit 230') can include an axial support strut 225.

[0189] Exemplary Frames with Other Configurations of Support Structures

[0190] Figure 10-19 Depicted are additional examples of frames that can be used in any of the prosthetic valves described herein (e.g., 10, 100, 150). As described more fully below, Figure 10-19 Each of the frames shown in the embodiment has a support structure, which includes two or more angled support arms and at least one axial support member. The support structure in these examples can divide the outflow unit of the frame into multiple subunits. Some of the subunits have a large area to facilitate the coronary artery passage through them. The support structure can prevent or limit the leaflets of the prosthetic valve from protruding outward through the large opening of the outflow unit during valve curling, and can also prevent or limit the natural leaflets from protruding inward through the outflow unit during the cardiac cycle. The support structure can also reduce the risk of leaflet wear, for example, by eliminating the apex formed between the angled support arms (e.g., joint portion 254). In addition, the axial support member in the support structure can improve the stability of the prosthetic valve and prevent any part of the support structure from protruding outward when curling, thereby allowing the prosthetic valve to move undisturbed axially in the delivery catheter.

[0191] Fig.10 and 10A-10B shows a ring-shaped frame 300 for a prosthetic valve according to one example. Figures 5A-5C Frame 260, frame 300 includes four rows (e.g., rows 322, 324, 326, 328) of angled struts 302. The first row 322 of angled struts (also referred to as "outflow struts") defines an outflow end 318, and the fourth row 328 of angled struts (also referred to as "inflow struts") defines an inflow end 316 of the frame 300. Frame 300 also includes a plurality of axial frame members 310 that bridge the first row 322 of angled struts and the second row 324 of angled struts. Fig.10 In the example depicted in , the axial frame member 310 includes three commissure supports 332 having corresponding commissure windows 336 and six axial posts 334. Two axial posts 334 are circumferentially distributed between each pair of adjacent commissure supports 332. The first row 322 of angled struts and the second row 324 of angled struts and the axial frame member 310 can define a row of six-sided first cells 330 (also referred to as "outflow cells"). The second row 324 of angled struts and the third row 326 of angled struts can define a row of four-sided second cells 338. The third row 326 of angled struts and the fourth row 328 of angled struts can define a row of four-sided third cells 340 (also referred to as "inflow cells"). In the depicted example, the frame 300 has nine first cells 330, nine second cells 338, and nine third cells 340.

[0192] The frame 300 also includes a plurality of support structures 350 connecting the plurality of axial frame members 310 and the second row 324 of angled struts. Fig.10 and 10A -10B, each support structure 350 includes two angled support arms 352 connecting two adjacent axial frame members 310 and an axial support member 354 bridging the two angled support arms 352 and the second row 324 of angled struts. When the frame 300 is used in a prosthetic valve, the outer skirt (e.g., 18, 106, 156) can be attached to the angled support arms 352 of each support structure 350. For example, the outflow edge portion of the outer skirt (e.g., 122, 152) can be connected to the angled support arms 352 via sutures or other means.

[0193] The angled support arms 352 can be similar to the arm portion 252 of the support member 250 described above. For example, each angled support arm 352 can be connected to a corresponding axial frame member 310 at a connection point 358. Fig. 10AAs shown in , two angled support arms 352 of two adjacent support structures 350 located on opposite sides of the axial frame member 310A may be connected to the axial frame member 310 at a connection point 358 .

[0194] Each axial frame member 310 has an upper end 310U connected to a first row 322 of angled struts and a lower end 310L connected to a second row 324 of angled struts. Fig.10 and 10A -10B, the connection point 358 is axially spaced from the upper end 310U. In some examples, the connection point 358 can be closer to the upper end 310U than the lower end 310L. In other examples, the upper end 310U can overlap with the connection point 358.

[0195] For each support structure 350, the two angled support arms 352 and the axial support member 354 are connected at a joint portion 356 so that the two angled support arms 352 and the axial support member 354 can define a Y-shaped configuration. The joint portion 356 can define the upper end of the axial support member 354. Fig. 10A As shown in , each Y-shaped support structure 350 can divide the corresponding outflow unit 330 into three openings or subunits: one upper subunit 330U and two lower subunits 330L. In the depicted example, the frame 300 has nine upper subunits 330U and eighteen lower subunits 330L. The width of each upper subunit 330U is twice the width of the lower subunit 330L.

[0196] exist Fig.10 and 10A -10B, each upper subunit 330U is six-sided, formed by two angled strut portions 304 located in the first row 322 of angled struts, two angled support arms 352, and two upper portions 312 of two axial frame members 310. In other examples, each upper unit 330U can be four-sided. For example, when the upper end 310U overlaps the connection point 358, each upper subunit 330U is defined by two angled strut portions 304 located in the first row 322 of angled struts and two angled support arms 352.

[0197] like Fig. 10A, the second row 324 of angled struts are joined together at alternating upper ends 324U and lower ends 324L (the upper ends 324U are closer to the outflow end 318 than the lower ends 324L). The axial support members 354 can be connected to the corresponding lower ends 324L of the second row 324 of angled struts. Therefore, the lower ends 324L of the angled struts in the second row 324 can also define the lower ends of the axial support members 354. In other words, the axial support members 354 terminate at the corresponding lower ends 324L.

[0198] In some examples, the angled support arms 352 can be substantially parallel to corresponding angled struts in the second row 324 of angled struts. Thus, each of the lower subunits 330L can have a parallelogram shape.

[0199] Each support structure 350 can be configured to be axially foldable. For example, similar to Figures 5A-5C The arm portion 252 is configured to expand radially from the frame 300 (see, for example Fig. 10A ) moves to a radial compression configuration (see e.g. Fig. 10B ), each pair of angled support arms 352 can be folded at the joint portion 356. When folded, the two angled support arms 352 of each support structure 350 can extend substantially parallel to and between two adjacent axial frame members 310. In addition, the axial support members 354 can move axially when the frame 300 moves from the radially expanded configuration to the radially compressed configuration.

[0200] In connection between the angled support arms 352 and the second row 324 of angled struts, the axial support member 354 can eliminate free vertices where the support arms 352 intersect each other, thereby reducing the risk of leaflet wear. The Y-shaped support structure 350 can also be constrained within a plane defined by the corresponding outflow unit 330 (e.g., any portion of the support structure 350 can be prevented from protruding outward when the frame 300 is curled), thereby improving the stability of the frame 300 (and the corresponding prosthetic valve). In addition, the Y-shaped support structure 350 can act as a barrier to prevent the leaflets of the prosthetic valve from bulging outward and / or prevent the natural leaflets from protruding inward through the outflow unit 330.

[0201] In some examples, the angled support arms 352 are narrower than the angled struts 302 in any row (e.g., 322, 324, 326, 328) of angled struts. In some examples, the axial support members 354 are narrower than the axial frame members 310 (including the commissure supports 332 and the axial posts 334).

[0202] In some examples, the angled support arms 352 are narrower than the axial support members 354. In other examples, the angled support arms 352 can have approximately the same width as the axial support members 354.

[0203] Fig. 10A Also shown is the relative position of the leaflet (e.g., 40 or 104) and the frame 300 after the leaflet is mounted to the frame 300 (the outer perimeter of the leaflet is shown in phantom) according to one example. As shown, the outflow edge 42 of the leaflet can extend across three outflow cells 330. The axial position of the outflow edge 42 can be anywhere between the upper end of the commissure window 336 and the upper end 310U of the axial frame member 310. Each commissure tab 44 of the leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly inserted into the corresponding commissure window 336. The tip edge 46 of the leaflet (the tip edge is located below the commissure tab 44 and opposite the outflow edge 42) can have a generally V-shaped profile. The tip edge 46 can extend along and be attached to four angled struts (e.g., 324a, 324b, 326a, and 326b) located on the second row 324 and the third row 326, respectively, and two angled strut portions (e.g., 306a and 306b) located on the fourth row 328. The apex region 48 of the leaflet can be aligned with the curved apex portion 307 (similar to the apex portion 307 of the inflow strut located at the inflow end 316 of the frame 300) Figure 5A-5B 207) alignment.

[0204] Fig.11 Segments of an annular frame 400 for a prosthetic valve according to another example are shown, wherein the frame segments are shown in a flattened configuration. Full frame 400 includes three such frame segments. Frame 400 is similar to frame 300, except that frame 400 has five rows (e.g., rows 422, 424, 426, 428, 429) of angled struts 402. In some examples, frame 400 may have a larger diameter than frame 300 when the frames are all in a radially expanded configuration. In some examples, frames similar to 300 and 400 may have more than five rows of angled struts.

[0205] exist Fig.11, a first row 422 of angled struts defines an outflow end 418, and a fifth row 429 of angled struts defines an inflow end 416 of the frame 400. Similar to the frame 300, the frame 400 includes a plurality of axial frame members 410 that bridge the first row 422 of angled struts and the second row 424 of angled struts. For example, the axial frame members 410 may include three commissure supports 432 having corresponding commissure windows 436 and nine axial columns 434. The three axial columns 434 may be circumferentially distributed between every two adjacent commissure supports 432. The first row 422 of angled struts and the second row 424 of angled struts and the axial frame members 410 may define a row of six-sided outflow cells 430. The fourth row 428 of angled struts and the fifth row 429 of angled struts may define a row of four-sided inflow cells 442. The second row 424 of angled struts, the third row 426 of angled struts, and the fourth row 428 of angled struts may define two intermediate rows of four-sided cells 438, 440. In this example, the number of cells in each row (430, 438, 440, 442) is twelve.

[0206] The framework 400 also includes a Fig.10 and 10A -10B, multiple support structures 450 of the support structure 350 depicted. For example, each support structure 450 has two angled support arms 452 that connect two adjacent axial frame members 410 and an axial support member 454 that bridges the two angled support arms 452 and the second row 424 of angled struts. Similarly, each support structure 450 can divide the outflow unit 430 into an upper subunit 430U and two lower subunits 430L. Therefore, the frame 400 has 12 upper subunits 430U and 24 lower subunits 430L.

[0207] Fig.11Also shown is the relative position of the leaflet (e.g., 40 or 104) and the frame 400 after the leaflet is mounted to the frame 400 (the outer perimeter of the leaflet is shown in phantom) according to one example. As shown, the outflow edge 42 of the leaflet can extend across four outflow cells 430. The axial position of the outflow edge 42 can be anywhere between the upper end of the commissure window 436 and the upper end 410U of the axial frame member 410. Each commissure tab 44 of the leaflet can mate with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly inserted into the corresponding commissure window 436. The tip edge 46 of the leaflet can extend along and be attached to six angled struts (e.g., 424a, 424b, 426a, 426b, 428a, and 428b) located on the second row 424, the third row 426, and the fourth row 428, respectively, and two angled strut portions (e.g., 406a and 406b) located on the fifth row 429. The apex region 48 of the leaflet can be aligned with the curved apex portion 407 (similar to the apex portion 407 of the inflow strut located at the inflow end 416 of the frame 400) Figure 5A-5B 207) alignment.

[0208] Fig.12 A segment of an annular frame 500 for a prosthetic valve shown in a flattened configuration according to another example is shown. The full frame 500 includes three such segments. The frame 500 is similar to the frame 300, except that the frame 500 has only three rows (e.g., 522, 524, 526) of angled struts 502. In some examples, the frame 500 can have a smaller diameter than the frame 300 when the frames are all in a radially expanded configuration.

[0209] exist Fig.12 In the example depicted in FIG, a first row 522 of angled struts defines an outflow end 518, and a third row 526 of angled struts defines an inflow end 516 of the frame 500. Similar to the frame 300, the frame 500 includes a plurality of axial frame members 510 that bridge the first row 522 of angled struts and the second row 524 of angled struts. For example, the axial frame members 510 may include three commissure supports 532 and three axial columns 534 having corresponding commissure windows 536. Each axial column is circumferentially positioned between two adjacent commissure supports 532. The first row 522 of angled struts and the second row 524 of angled struts and the axial frame members 510 may define a row of six-sided outflow cells 530. The second row 524 of angled struts and the third row 526 of angled struts may define a row of four-sided inflow cells 538. In this example, the frame 500 has six outflow cells 530 and six inflow cells 538.

[0210] The framework 500 also includes a Fig.10 and 10A -10B. For example, each support structure 550 has two angled support arms 552 connecting two adjacent axial frame members 510 and an axial support member 554 bridging the two angled support arms 552 and the second row 524 of angled struts. Similarly, each support structure 550 can divide the outflow unit 530 into an upper subunit 530U and two lower subunits 530L. Therefore, the frame 500 has six upper subunits 530U and twelve lower subunits 530L.

[0211] Fig.12 Also shown is the relative position of the leaflet (e.g., 40 or 104) and the frame 500 after the leaflet is mounted to the frame 500 (the outer perimeter of the leaflet is shown in phantom) according to one example. As shown, the outflow edge 42 of the leaflet can extend across two outflow cells 530. The axial position of the outflow edge 42 can be anywhere between the upper end of the commissure window 536 and the upper end 510U of the axial frame member 510. Each commissure tab 44 of the leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly inserted into the corresponding commissure window 536. The tip edge 46 of the leaflet can extend along and be attached to two angled struts (e.g., 524a, 524b) located in the second row 524 and two angled strut portions (e.g., 506a and 506b) located in the second row 526. The apex region 48 of the leaflet may be aligned with the curved apex portion 507 of the inflow strut at the inflow end 516 of the frame 500 (similar to Figure 5A-5B 207) alignment.

[0212] Fig.13Another example of a section of a frame 500' similar to frame 500 is shown, except that frame 500' includes additional angled support members 540, 542 interconnected with the third row of angled struts 526. Six of the angled support members 540 are positioned with the inflow unit 538, each bridging two angled strut portions (e.g., 506a and 506b) of the corresponding inflow strut. The other six angled support members 542 are positioned outside the inflow unit 538, each bridging an angled strut portion (e.g., 506a or 506b) of an inflow strut and an adjacent angled strut portion of an adjacent inflow strut. Each angled support member 540 has an arc angle A1 pointing to the inflow end 516, and each angled support member 542 has an arc angle A2 pointing to the outflow end 518. When the frame 500' is in a radially expanded configuration, the arc angle A1 can be less than the arc angle A2. Each angled support member 540 can divide the corresponding inflow unit 538 into an upper subunit 538U and a lower subunit 538L. Each angled support member 542 can form an additional lower subunit 538L' by bridging two adjacent angled strut portions.

[0213] Fig.14 Another one-third section of an annular frame 600 for a prosthetic valve according to another example is shown. Similar to frame 300, frame 600 has four rows (e.g., rows 622, 624, 626, 628) of angled struts 602, wherein the first row 622 of angled struts defines an outflow end 618, and the fourth row 628 of angled struts defines an inflow end 616 of frame 600. Similarly, frame 600 includes a plurality of axial frame members 610 (e.g., three commissure supports 632 and six axial posts 634 with corresponding commissure windows 636) bridging the first row 622 of angled struts and the second row 624 of angled struts. The first row 622 of angled struts and the second row 624 of angled struts and the axial frame members 610 can define a row of six-sided outflow cells 630. The second row 624 of angled struts and the third row 626 of angled struts can define an intermediate row of four-sided cells 638. The third row 626 of angled struts and the fourth row 628 of angled struts may define a row of six-sided inflow cells 640 .

[0214] The frame 600 also includes a plurality of support structures 650. Each support structure 650 has two angled support arms 652 that connect two adjacent axial frame members 610 and an axial support member 654 that bridges the two angled support arms 652 and the second row 624 angled struts. Unlike the frame 300 in which the axial support members 354 terminate at the corresponding lower ends 324L of the angled struts in the second row 324, the axial support members 654 of the frame 600 extend further downward (toward the inflow end 616) and bridge the second row 624 angled struts and the fourth row 628 angled struts (i.e., inflow struts). Thus, each axial support member 654 can divide the corresponding six-sided inflow unit 640 into two four-sided subunits 640a, 640b. The inflow struts of the frame 600 (located at the fourth row 628) form a zigzag pattern and define a plurality of upper ends 628U located downstream of the inflow end 616. The axial support members 654 of the support structure 650 connect the lower ends 624L of the second row 624 of angled struts to the corresponding upper ends 628U of the inflow struts. Each of the remaining upper ends 628U of the inflow struts is connected to two angled struts of the third row 626 of angled struts. In this example, the ratio of the number of vertices 605 defined by the outflow struts to the number of vertices 607 defined by the inflow struts is 1:2.

[0215] Fig.14 Also shown is the relative position of the leaflet (e.g., 40 or 104) and the frame 600 after the leaflet is mounted to the frame 600 (the outer perimeter of the leaflet is shown in phantom) according to one example. As shown, the outflow edge 42 of the leaflet can extend across three outflow cells 630. The axial position of the outflow edge 42 can be located anywhere between the upper end of the commissure window 636 and the upper end 610U of the axial frame member 610. Each commissure tab 44 of the leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly inserted into the corresponding commissure window 636. The tip edge 46 of the leaflet can extend along and be attached to at least four angled struts (e.g., struts 624a, 624b, 626a, and 626b) located on the second row 624 and the third row 626, respectively. In some instances, the tip edge 46 of the leaflet can also be attached to the two angled strut portions (e.g., struts 606a, 606b) of the inflow strut. Alternatively, the tip edge 46 of the leaflet can be detached from the inflow strut. The apex region 48 of the leaflet can be located at the inflow end 616 of the frame 600. Fig.14 In the example depicted in , the apex region 48 of the leaflet is not connected to any struts of the frame 600. The apex 49 of the leaflet can be located upstream of the junction 625, where the axial support member 654 is connected to the inflow struts.

[0216] Fig.15 A third section of an annular frame 700 for a prosthetic valve according to another example is shown. The frame 700 has four rows (e.g., rows 722, 724, 726, 728) of angled struts 702, wherein the first row 722 of angled struts defines an outflow end 718, and the fourth row 728 of angled struts defines an inflow end 716 of the frame 700. The upper half of the frame (closer to the outflow end 718) and the lower half of the frame (closer to the inflow end 716) are mirror images of each other. For example, the frame 700 includes a plurality of first axial frame members 710 (similar to the frame members 310) bridging the first row 722 of angled struts and the second row 724 of angled struts, and a plurality of second axial frame members 710' (the second axial frame members are mirror images of the corresponding first axial frame members 710) bridging the third row 726 of angled struts and the fourth row 728 of angled struts. In addition, the frame 700 includes a plurality of first support structures 750 and a plurality of second support structures 750'. Each first support structure 750 has two angled support arms 752 connecting two immediately adjacent first axial frame members 710 and an axial support member 754 bridging the two angled support arms 752 and the second row 724 of angled struts. Each second support structure 750' has two angled support arms 752' connecting two immediately adjacent second axial frame members 710' and an axial support member 754' bridging the two angled support arms 752' and the third row 726 of angled struts. Thus, each second support structure 750' defines an inverted Y-shaped configuration. The axial support members 754 of the first support structure 750 are connected to the axial support members 754' of the second support structure 750' at the joint 760 located between the second row 724 of angled struts and the third row 726 of angled struts so that each first support structure 750 is a mirror image of the corresponding second support structure 750'.

[0217] Fig.16A third section of an annular frame 800 for a prosthetic valve according to another example is shown. The frame 800 has four rows (e.g., rows 822, 824, 826, 828) of angled struts 802. The first row 822 of angled struts defines an outflow end 818, and the fourth row 828 of angled struts defines an inflow end 816 of the frame 800. Similarly, the frame 800 includes a plurality of axial frame members 810 (e.g., three commissure supports 832 and three axial columns 834 with corresponding commissure windows 836), which bridge the first row 822 of angled struts and the second row 824 of angled struts. The first row 822 of angled struts, the second row 824 of angled struts, and the axial frame members 810 can define a row of eight-sided outflow cells 830. The second row 824 of angled struts and the third row 826 of angled struts can define an intermediate row of four-sided cells 838. The third row 826 of angled struts and the fourth row 828 of angled struts may define a row of four-sided inflow cells 840. In this example, there are six outflow cells 830, twelve inflow cells 840, and twelve cells 838 in the middle row.

[0218] The frame 800 also includes a plurality of support structures 850. Fig.16 As shown in , each support structure 850 can have four angled support arms 852, which are interconnected to define a W-shaped configuration. The four angled support arms 852 may include two side support arms 852a respectively connected to two adjacent axial frame members 810 and two intermediate support arms 852b positioned between the two side support arms 852a. The second row 824 angled pillars are joined together at alternating upper ends 824U and lower ends 824L. Each support structure 850 further includes an intermediate axial support member 854, which connects the joint 856 of the two intermediate support arms 852b and the corresponding upper ends 824U of the second row 824 angled pillars. Therefore, each support structure 850 can divide the corresponding outflow unit 830 into an upper subunit 830U and two lower subunits 830L. As shown Fig.16 As shown in , each lower subunit 830L is six-sided, and the width of the upper subunit 830U is twice the width of each lower subunit 830L. Fig.16 In the example depicted in , each side support arm 852a is connected to an adjacent axial frame member 810 at a connection point 858 axially spaced apart from the upper end 810U of the axial frame member 810. In other examples, the connection point 858 may overlap with the upper end 810U.

[0219] Fig.16Also shown is the relative position of the leaflet (e.g., 40 or 104) and the frame 800 after the leaflet is mounted to the frame 800 (the outer perimeter of the leaflet is shown in phantom) according to one example. As shown, the outflow edge 42 of the leaflet can extend across two outflow cells 830. The axial position of the outflow edge 42 can be located anywhere between the upper end of the commissure window 836 and the upper end 810U of the axial frame member 810. Each commissure tab 44 of the leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly inserted into the corresponding commissure window 836. The tip edge 46 of the leaflet can extend along and be attached to at least four angled struts (e.g., 824a, 824b, 826a, and 826b) located on the second row 824 and the third row 826, respectively. In some instances, the tip edge 46 of the leaflet can also be attached to the two angled strut portions (e.g., 806a and 806b) of the inflow strut. Alternatively, the tip edge 46 of the leaflet can be detached from the inflow strut. The apex region 48 of the leaflet can be located at the inflow end 816 of the frame 800. Fig.16 In the example depicted in , the apex region 48 of the leaflet is not connected to any struts of the frame 800. The apex 49 of the leaflet can be located upstream of the junction 825 where the third row 826 of angled struts connects to the fourth row 828 of angled struts.

[0220] Fig.17 FIG. 8 shows a third section of an annular frame 800' for a prosthetic valve according to another example. Frame 800' is similar to frame 800 except that it has a different support structure 850'. Fig.17 As shown in , each support structure 850' also has four angled support arms 852 (including two side support arms 852a and two middle support arms 852b), which are interconnected to define a W-shaped configuration, and an intermediate axial support member 854, which connects the joint 856 of the two middle support members 852b and the corresponding upper ends 824U of the second row 824 angled pillars. In addition, each support structure 850' further includes two side axial support members 855 located on opposite sides of the middle support member 854. Each side axial support member 855 can connect one of the lower ends 824L of the second row 824 angled pillars and the joint 853 formed between the side support arm 852a and the adjacent middle support arm 852b. Therefore, each support structure 850' can divide the corresponding outflow unit 830 into an upper subunit 830U and four lower subunits 830L. The width of each of the lower subunits 830L is one-fourth of the width of the upper subunit 830U. As shown in the figure, each of the lower sub-units 830L may have a parallelogram shape.

[0221] Fig.18 A third section of an annular frame 900 for a prosthetic valve according to another example is shown. The frame 900 has five rows (e.g., rows 922, 924, 926, 928, 929) of angled struts 902. The first row 922 of angled struts defines an outflow end 918, and the fifth row 929 of angled struts defines an inflow end 916 of the frame 900. Similarly, the frame 900 includes a plurality of axial frame members 910 (e.g., three commissure supports 932 and three axial posts 934 with corresponding commissure windows 936), which bridge the first row 922 of angled struts and the second row 924 of angled struts.

[0222] In this example, while the angled struts in each of the other four rows (rows 922, 926, 928, 929) are interconnected to form a circumferentially continuous row of angled struts, the angled struts in the second row 924 are discontinuous. Fig.18 , two angled struts 924c, 924d in the second row 924 can be connected to the lower end 910L of the corresponding axial frame member 910. However, the same two angled struts 924c, 924d are not directly connected to any other angled struts (e.g., 924a, 924b) in the second row 924 of angled struts. In this example, the second row 924 has only 12 angled struts, while each of the third row 926 and the fourth row 928 has 24 angled struts.

[0223] exist Fig.18 In the example depicted in FIG. 1 , the first row 922 of angled struts, the second row 924 of angled struts, and the third row 926 of angled struts and the axial frame member 910 can define a row of six-sided outflow cells 930. The second row 924 of angled struts and the third row 926 of angled struts can define an upper intermediate row of four-sided cells 938. The third row 826 of angled struts and the fourth row 828 of angled struts can define a lower intermediate row of four-sided cells 940. The fourth row 928 of angled struts and the fifth row 928 of angled struts can define a row of four-sided inflow cells 942. In this example, there are six outflow cells 930, six cells 938 in the upper intermediate row, twelve cells 940 in the lower intermediate row, and twelve inflow cells 942. Due to the discontinuity of the angled struts in the second row 924, each cell 938 in the upper intermediate row is also not directly connected to any other cell 938 in the upper intermediate row.

[0224] The frame 900 also includes a plurality of support structures 950 connecting the plurality of axial frame members 910 and the second row 924 of angled struts and the third row 926 of angled struts. In this example, each support structure 950 includes two angled support arms 952 connecting two adjacent axial frame members 910 and three axial support members 954 bridging the two angled support arms 952 and the second row 924 of angled struts and the third row 926. Fig.18 As shown in , the three axial support members 954 include an intermediate axial support member 954b and two side axial support members 954a. The intermediate axial support member 954b has an upper end connected to a joint 956 of two angled support arms 952. The two side axial support members 954a have respective upper ends connected to corresponding midpoints 957 of the two angled support arms 952 (i.e., each side axial support member 954a divides the corresponding angled support arm 952 into two). In addition, each support structure 950 further includes a connecting support member 951 connecting the midpoints 957 of the two angled support arms 952. For a prosthetic valve having an outer skirt, the outer skirt can be attached to at least a portion of the support structure 950 (e.g., a portion of the angled support arms 952 and / or the connecting support member 951).

[0225] In some examples, the angled support arms 952 and connecting support members 951 are narrower than the outflow struts (located in the first row 922) and the inflow struts (located in the fifth row 929). In some examples, the axial support members 954 are narrower than the axial frame members 910.

[0226] like Fig.18 , two angled support arms 952 of two adjacent support structures 950 located on opposite sides of the axial frame member 910 can be connected to the axial frame member 910 at a connection point 958. In the depicted example, the connection point 958 is axially spaced from the upper end 910U of the axial frame member 910. In other examples, the upper end 910U of the axial frame member 910 can overlap with the connection point 958.

[0227] The third row 926 of angled struts are joined together at alternating upper ends 926U and lower ends 926L. Each of the angled struts in the second row 924 of angled struts is connected to one of the upper ends 926U of the third row 926 of angled struts. Fig.18As depicted in , for each support structure 950, the lower end of the intermediate axial support member 954b can be connected to one of the lower ends 926L of the third row 926 of angled struts, and the lower end of each side axial support member 954a can be connected to one of the upper ends 926U of the third row 926 of angled struts.

[0228] exist Fig.18 In the example depicted in , each support structure 950 can divide the corresponding outflow unit 930 into six subunits, the six subunits including a row of four lower subunits 930L, one middle subunit 930M and one upper subunit 930U arranged in a V-shaped pattern. Each of the four lower subunits 930L has a parallelogram shape. The middle subunit 930M has four sides. The upper subunit 930U can have eight sides (if the connection point 958 is axially spaced from the upper end 910U of the axial frame member 910) or have six sides (if the upper end 910U of the axial frame member 910 overlaps with the connection point 958).

[0229] Fig.18 Also shown is the relative position of the leaflet (e.g., 40 or 104) and the frame 900 after the leaflet is mounted to the frame 900 (the outer perimeter of the leaflet is shown in phantom) according to one example. As shown, the outflow edge 42 of the leaflet can extend across two outflow cells 930. The axial position of the outflow edge 42 can be located anywhere between the upper end of the commissure window 936 and the upper end 910U of the axial frame member 910. Each commissure tab 44 of the leaflet can mate with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly inserted into the corresponding commissure window 936. The tip edge 46 of the leaflet can extend along and be attached to the six angled struts (e.g., struts 924a, 924b, 926a, 926b, 928a, and 928b) located in the second row 924, the third row 926, and the fourth row 928, respectively, and the two angled strut portions (e.g., struts 906a and 906b) located in the fifth row 929. The apex region 48 of the leaflet can be aligned with the curved apex portion 907 (similar to the apex portion 907 of the inflow strut located at the inflow end 916 of the frame 900) Figure 5A-5B 207) alignment.

[0230] Fig.19A third section of an annular frame 900' for a prosthetic valve according to another example is shown. Similar to frame 900, frame 900' has five rows (e.g., 922, 924, 926, 928, 929) of angled struts 902, wherein the first row 922 of angled struts defines an outflow end 918, and the fifth row 929 of angled struts defines an inflow end 916 of frame 900. Frame 900' also includes a plurality of axial frame members 910 bridging the first row 922 of angled struts and the second row 924 of angled struts. Unlike frame 900, the axial frame members 910 of frame 900' include three commissure supports 932, but do not have an axial column (e.g., column 934) located between the commissure supports 932 and bridging the first row 922 of angled struts and the second row 924 of angled struts. Similar to frame 900, while the angled struts in each of the other four rows (922, 926, 928, 929) are interconnected to form a circumferentially continuous row of angled struts, the angled struts in the second row 924 are discontinuous. In this example, the second row 924 has only 6 angled struts, while each of the third row 926 and the fourth row 928 has 24 angled struts.

[0231] exist Fig.19 In the example depicted in FIG. 1 , a first row 922 of angled struts, a second row 924 of angled struts, and a third row 926 of angled struts and an axial frame member 910 can define a row of twelve outflow cells 930. The second row 924 of angled struts and the third row 926 of angled struts can define an upper intermediate row of four-sided cells 938 (located directly below the corresponding commissure supports 932). The third row 826 of angled struts and the fourth row 828 of angled struts can define a lower intermediate row of four-sided cells 940. The fourth row 928 of angled struts and the fifth row 928 of angled struts can define a row of four-sided inflow cells 942. In this example, due to the lack of axial struts, there are only three outflow cells 930 and three cells 938 in the upper intermediate row, while there are twelve cells 940 in the lower intermediate row, and there are twelve inflow cells 942. Due to the discontinuity of the angled struts in the second row 924, the cells 938 in the upper intermediate row are not directly connected to each other.

[0232] The frame 900' may have three support structures 950' connecting the three axial frame members 910 and the second row 924 of angled struts and the third row 926 of angled struts. Fig.19As shown in , each support structure 950' includes eight angled support arms 952 and four axial support members 954. Each axial support member 954 has an upper end connected to a corresponding joint 956 of two angled support arms 952 and a lower end connected to a corresponding upper end 926U of a third row 926 angled pillar. In this example, each support structure 950 can divide the corresponding outflow unit 930 into seven subunits, the subunits including a row of five lower subunits 930L' and two upper subunits 930U'. The five lower subunits 930L' include three hexahedral subunits 930a (each subunit has a parallelogram) located between two tetrahedral subunits 930b.

[0233] Exemplary expansion mechanisms for prosthetic valves

[0234] For any prosthetic valve in the prosthetic valve described herein, the framework can be made of any of various suitable plastic expansion materials. When made of plastic expansion materials, the framework (and therefore the prosthetic valve) can be curled into a radially collapsed configuration on a delivery catheter or device, and then expanded in the patient by an inflatable balloon or an equivalent expansion mechanism. In some instances, during delivery to the implantation site, the prosthetic valve can be placed inside a delivery capsule or sheath to protect the prosthetic valve from contacting the patient's vascular system, such as when the prosthetic valve is advanced through the femoral artery. The capsule can also maintain the prosthetic valve in a radially compressed state, and the diameter and curling profile of the radially compressed state are slightly smaller than the diameter and curling profile when there is no capsule by preventing the framework from any rebound (expansion) after curling on the delivery device.

[0235] Suitable plastic expansion materials that can be used to form any of the frameworks disclosed herein include metal alloys, polymers, or combinations thereof. Example metal alloys can include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, the framework can include stainless steel. In some instances, the framework can include cobalt chromium. In some instances, the framework can include nickel cobalt chromium. In some instances, the framework includes a nickel cobalt chromium molybdenum alloy, such as MP35N. TM (trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium and 10 wt% molybdenum.

[0236] Additional details regarding balloon-expandable prosthetic valves can be found in U.S. Patent No. 9,393,110, as well as U.S. Provisional Application No. 63 / 178,416 filed on April 22, 2021, U.S. Provisional Application No. 63 / 194,830 filed on May 28, 2021, and U.S. Provisional Application No. 63 / 279,096 filed on November 13, 2021, all of which are incorporated herein by reference.

[0237] Any prosthetic valve in the prosthetic valve described herein can be self-expandable.For example, the frame of the prosthetic valve can include shape memory material (e.g., nitinol).When the prosthetic valve is self-expandable, the frame (and therefore the prosthetic valve) can be curled into a radially compressed configuration and be limited in a compressed configuration by being inserted into a sheath or equivalent mechanism of a delivery catheter.Once entering the implantation site required in the body, the prosthetic valve can be launched or released from the delivery sheath, which allows the prosthetic valve to expand to its functional size.In some instances, the frame (and therefore the prosthetic valve) can be partially self-expandable from a radially compressed configuration to a partially radially expanded configuration.The frame (and therefore the prosthetic valve) can be further radially expanded from a partially expanded configuration to a further radially expanded configuration via one or more actuating assemblies (e.g., inflatable balloons and / or one or more mechanical actuators) of a delivery device.

[0238] Additional details regarding exemplary self-expandable prosthetic valves and related delivery apparatus / catheters / systems are described in U.S. Patent Nos. 8,652,202; 9,155,619; and 9,867,700, all of which are incorporated herein by reference.

[0239] Additionally and / or alternatively, any of the prosthetic valves described herein can be mechanically expandable. For example, the struts of the frame can be pivotally coupled to each other at one or more pivot joints along the length of each strut. Thus, an axial force applied to the frame (e.g., pressing the inflow and outflow ends of the frame toward each other or pulling the inflow and outflow ends of the frame away from each other) can cause the prosthetic valve to radially expand or compress. The axial force can be generated by actuating one or more mechanical actuators of a delivery device operatively coupled to the frame.

[0240] Additional details regarding exemplary mechanically expandable prosthetic valves and related delivery devices / catheters / systems are described in U.S. Patent Application Publication Nos. 2018 / 0153689, 2018 / 0311039, 2019 / 0060057, and PCT Patent Application Publication No. WO / 2021 / 188476, all of which are incorporated herein by reference.

[0241] Exemplary Delivery Devices

[0242] Fig. 20 A delivery device 1000 is shown according to an example that can be used to implant an expandable prosthetic valve (e.g., any of the prosthetic valves 10, 100, 150, and / or other prosthetic valves described herein). In some examples, the delivery device 300 can be specifically adapted for introducing a prosthetic valve into a heart.

[0243] Fig. 20 The delivery device 1000 in the illustrated example is a balloon catheter comprising a handle 1002 and a steerable outer shaft 1004 extending distally from the handle 1002. The delivery device 1000 may further comprise an intermediate shaft 1006 (which may also be referred to as a balloon shaft) extending proximally from the handle 1002 and extending distally from the handle 1002, the portion extending distally from the handle 1002 also coaxially extending through the outer shaft 1004. Additionally, the delivery device 1000 may further comprise an inner shaft 1008 extending distally from the handle 1002 coaxially through the intermediate shaft 1006 and the outer shaft 1004, and extending proximally from the handle 1002 coaxially through the intermediate shaft 1006.

[0244] The outer shaft 1004 and the intermediate shaft 1006 can be configured to translate (eg, move) longitudinally relative to each other along a central longitudinal axis 1020 of the delivery device 1000 to facilitate delivery and positioning of a prosthetic valve at an implantation site within a patient.

[0245] The intermediate shaft 1006 may include a proximal portion 1010 extending proximally from the proximal end of the handle 1002 to the adapter 1012. A rotatable knob 1014 may be mounted on the proximal portion 1010 and may be configured to rotate the intermediate shaft 1006 about the central longitudinal axis 1020 and relative to the outer shaft 1004.

[0246] The adapter 1012 may include a first port 1038 configured to receive a guidewire therethrough and a second port 1040 configured to receive a fluid (eg, an inflation fluid) from a fluid source. The second port 1040 may be fluidly coupled to the inner lumen of the intermediate shaft 1006.

[0247] The intermediate shaft 1006 can further include a distal portion that extends distally beyond the distal end of the outer shaft 1004 when the distal end of the outer shaft 1004 is positioned away from the expandable balloon 1018 of the delivery device 1000. The distal portion of the inner shaft 1008 can extend distally beyond the distal portion of the intermediate shaft 1006.

[0248] The balloon 1018 can be connected to the distal portion of the intermediate shaft 1006.

[0249] In some examples, the distal end of the balloon 1018 can be coupled to the distal end of the delivery device 1000, such as to the nose cone 1022, or to an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 1000. The middle portion of the balloon 1018 can cover the valve mounting portion 1024 of the distal portion of the delivery device 1000, and the distal portion of the balloon 1018 can cover the distal shoulder 1026 of the delivery device 1000. The valve mounting portion 1024 and the middle portion of the balloon 1018 can be configured to accommodate a prosthetic valve in a radially compressed state. For example, as in Fig. 20 As schematically shown in FIG. 1 , a prosthetic valve 1050 , which may be one of the prosthetic valves described herein, may be mounted around a balloon 1018 at a valve mounting portion 1024 of the delivery device 1000 .

[0250] The balloon shoulder assembly, including the distal shoulder 1026, can be configured to maintain a prosthetic valve 1050 (or other medical device) in a fixed position on the balloon 1018 during delivery through the patient's vasculature.

[0251] The outer shaft 1004 may include a distal tip portion 1028 mounted on its distal end. When the prosthetic valve 1050 is mounted on the valve mounting portion 1024 in a radially compressed state (e.g., Fig. 20 ) and during delivery of the prosthetic valve to a target implantation site, the outer shaft 1004 and the intermediate shaft 1006 can be axially translated relative to each other to position the distal tip portion 1028 adjacent to the proximal end of the valve mounting portion 1024. Therefore, when the distal tip portion 1028 is disposed proximal to the valve mounting portion 1024, the distal tip portion 1028 can be configured to resist proximal movement of the prosthetic valve 1050 relative to the balloon 1018 in an axial direction relative to the balloon 1018.

[0252] An annular space can be defined between the outer surface of the inner shaft 1008 and the inner surface of the intermediate shaft 1006, and can be configured to receive fluid from a fluid source via the second port 1040 of the adapter 1012. The annular space can be fluidly coupled to a fluid passage formed between the outer surface of the distal portion of the inner shaft 1008 and the inner surface of the balloon 1018. Thus, the fluid from the fluid source can flow from the annular space to the fluid passage to inflate the balloon 1018 and radially expand and deploy the prosthetic valve 1050.

[0253] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for guiding the distal portion of the delivery device 1000 to a target implantation site.

[0254] The handle 1002 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 1000. In the illustrated example, for example, the handle 1002 includes an adjustment member, such as a rotatable knob 1060 as shown, which may be further operatively coupled to a proximal portion of a pull wire. The pull wire may extend distally from the handle 1002 through the outer shaft 1004 and have a distal portion fixed to the outer shaft 1004 at or near the distal end of the outer shaft 1004. Rotating the knob 1060 may increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal portion of the delivery device 1000. Additional details regarding a steering or bending mechanism for a delivery device may be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0255] The handle 1002 can further include an adjustment mechanism 1061 and an associated locking mechanism, the adjustment mechanism including an adjustment member, such as a rotatable knob 1062 as shown, the locking mechanism including another adjustment member configured as a rotatable knob 1078. The adjustment mechanism 1061 can be configured to adjust the axial position of the intermediate shaft 1006 relative to the outer shaft 1004 (e.g., for fine positioning at the implantation site). Additional details about the delivery device 1000 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0256] Despite Fig. 20 The delivery device 1000 depicted in the drawings is particularly suitable for delivering balloon-expandable prosthetic valves, but it will be understood that variations of the delivery device 1000 may be suitable for delivering self-expandable prosthetic valves and / or mechanically expandable prosthetic valves, as described in the references incorporated above.

[0257] Exemplary Delivery Techniques

[0258] In order to implant the prosthetic valve in the natural aortic valve by the femoral delivery method, the prosthetic valve can be installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device can be inserted into the femoral artery and then advanced into the descending aorta and passed through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve can be positioned in the natural aortic valve and (for example, by inflating the balloon, actuating one or more actuators of the delivery device or causing the prosthetic valve to unfold from the sheath to allow the prosthetic valve to self-expand) radially expand. Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical surgery, whereby the prosthetic valve (located on the distal portion of the delivery device) can be introduced into the left ventricle through the surgical opening in the chest and apex, and the prosthetic valve can be positioned in the natural aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (located on the distal portion of the delivery device) can be introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0259] To implant a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve can be mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device can be inserted into the femoral vein and then advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (e.g., through a perforation made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (located on the distal portion of the delivery device) can be introduced into the left ventricle through a surgical opening in the chest and apex, and the prosthetic valve can be positioned within the native mitral valve.

[0260] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve can be installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device can be inserted into the femoral vein, and then advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve can be positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve can be advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0261] Another delivery method is a transatrial approach, whereby a prosthetic valve (located on the distal portion of the delivery device) can be inserted through an incision in the chest and an incision made through the atrial wall (of the right or left atrium) to access any of the native heart valves. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Still another delivery method is a transventricular approach, whereby a prosthetic valve (located on the distal portion of the delivery device) can be inserted through an incision in the chest and an incision made through the wall of the right ventricle (usually at the base of the heart) for implantation of the prosthetic valve in the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0262] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0263] It should be understood that the therapeutic techniques, methods, steps, etc. described or suggested herein or incorporated by reference herein can be performed on living animals or on non-living simulated objects, such as cadavers, cadaver hearts, anthropomorphic false targets, simulators (e.g., having simulated body parts, tissues, etc.).

[0264] Sterilization

[0265] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that it is safe for use by patients, and as a step in the steps of the method, any method in the method herein can include the sterilization of the associated systems, devices, equipment, etc. The example of heating / thermal sterilization includes steam sterilization and autoclave sterilization. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, the sterilization carried out with hydrogen peroxide can be completed using hydrogen peroxide plasma.

[0266] Additional Examples of the Disclosed Technology

[0267] Considering the above-described embodiments of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or more than one feature of an example adopted in combination and optionally combined with one or more features of one or more additional examples are additional examples that also fall within the disclosure of the present application.

[0268] Example 1. A prosthetic valve comprising: an annular frame that can radially collapse to a collapsed configuration and can radially expand to an expanded configuration; and an outer skirt that is disposed on the outer surface of the annular frame, wherein the annular frame comprises: an inflow end; an outflow end; a first row of angled struts defining the outflow end; a second row of angled struts that is closer to the inflow end than the first row of angled struts; a plurality of axial frame members bridging the first row of angled struts and the second row of angled struts; and a plurality of support members connecting the plurality of axial frame members, wherein the support members are narrower than the axial frame members and the first row of angled struts and the second row of angled struts, and wherein the outer skirt is connected to the support members.

[0269] Example 2. A prosthetic valve according to any example herein, in particular Example 1, further comprising a leaflet structure positioned within the annular frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end.

[0270] Example 3. A prosthetic valve according to any example herein, in particular Example 2, further comprising an inner skirt attached to the inner surface of the annular frame, wherein the leaflet structure is connected to the inner skirt.

[0271] Example 4. A prosthetic valve according to any example described herein, in particular any one of Examples 2 to 3, wherein the plurality of axial frame members comprise a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support is configured to support a corresponding commissure of the leaflet structure.

[0272] Example 5. A prosthetic valve according to any example herein, particularly Example 4, wherein the leaflet structure comprises three leaflets defining three commissures, and the plurality of axial frame members comprises three axially extending commissure supports.

[0273] Example 6. A prosthetic valve according to any example herein, in particular any one of examples 4 to 5, wherein there are two axial posts located between any two adjacent commissure supports.

[0274] Example 7. A prosthetic valve according to any example herein, particularly any one of Examples 1 to 6, wherein the first row of angled struts and the second row of angled struts are narrower than the plurality of axial frame members.

[0275] Example 8. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 7, wherein the second row of angled struts is narrower than the first row of angled struts.

[0276] Example 9. A prosthetic valve according to any example described herein, in particular any one of Examples 1 to 8, wherein the first row of angled struts are joined together at a first set of alternating upper and lower ends, the upper ends defining the outflow end and the lower ends being closer to the inflow end than the upper ends, wherein the second row of angled struts are joined together at a second set of alternating upper and lower ends, the upper ends being closer to the outflow end than the lower ends, and wherein the plurality of axial frame members respectively connect the lower ends of the first row of angled struts to the upper ends of the second row of angled struts.

[0277] Example 10. A prosthetic valve according to any example herein, in particular Example 9, wherein each support member is connected to the upper ends of two adjacent axial frame members.

[0278] Example 11. A prosthetic valve according to any example herein, in particular Example 9, wherein each support member is connected to two adjacent axial frame members at a corresponding connection point, wherein the connection point is located between the lower end of the first row and the upper end of the second row connected by the corresponding axial frame members.

[0279] Example 12. A prosthetic valve according to any example herein, particularly Example 11, wherein at least some of the support members include openings axially spaced apart from the corresponding connection points.

[0280] Example 13. A prosthetic valve according to any example herein, in particular any one of examples 1 to 12, wherein the annular frame comprises at least four rows of angled struts.

[0281] Example 14. A prosthetic valve according to any example herein, particularly Example 13, wherein the annular frame further comprises a third row of angled struts closer to the inflow end than the second row of angled struts and a fourth row of angled struts defining the inflow end.

[0282] Example 15. A prosthetic valve according to any example herein, particularly Example 14, wherein the third row of angled struts is narrower than the fourth row of angled struts.

[0283] Example 16. A prosthetic valve according to any example herein, in particular any one of Examples 14 to 15, wherein the width of the second row of angled struts is the same as the width of the third row of angled struts.

[0284] Example 17. A prosthetic valve according to any example herein, particularly any one of Examples 14 to 16, wherein the width of the fourth row of angled struts is the same as the width of the first row of angled struts.

[0285] Example 18. A prosthetic valve according to any example described herein, in particular any one of Examples 14 to 17, wherein the first row of angled struts, the second row of angled struts, and the plurality of axial frame members define a plurality of first units of the annular frame, wherein the support members divide the first units into respective upper unit portions and lower unit portions, the upper unit portions being closer to the outflow end than the lower unit portions.

[0286] Example 19. A prosthetic valve according to any example herein, in particular Example 18, wherein the first unit has a hexagonal shape when the annular frame is in an expanded configuration.

[0287] Example 20. A prosthetic valve according to any example herein, in particular any one of Examples 18 to 19, wherein the upper unit portion is larger than the lower unit portion when the annular frame is in the expanded configuration.

[0288] Example 21. A prosthetic valve according to any example herein, in particular any one of Examples 18 to 19, wherein the lower unit portion is larger than the upper unit portion when the annular frame is in the expanded configuration.

[0289] Example 22. A prosthetic valve according to any example herein, in particular any one of Examples 18 to 19, wherein the upper unit portion and the lower unit portion are the same size when the annular frame is in the expanded configuration.

[0290] Example 23. A prosthetic valve according to any example herein, in particular any one of examples 18 to 22, wherein the lower unit portion has a quadrilateral shape when the annular frame is in the expanded configuration.

[0291] Example 24. A prosthetic valve according to any example herein, in particular any one of Examples 18 to 22, wherein when the annular frame is in the expanded configuration, neither the upper portion nor the lower portion has a quadrilateral shape.

[0292] Example 25. A prosthetic valve according to any example herein, in particular any one of Examples 18 to 24, wherein the second row of angled struts and the third row of angled struts define a plurality of second units of the annular frame, and wherein the third row of angled struts and the fourth row of angled struts define a plurality of third units of the annular frame.

[0293] Example 26. A prosthetic valve according to any example herein, in particular Example 25, wherein each of the second unit and the third unit has a quadrilateral shape when the annular frame is in the expanded configuration.

[0294] Example 27. A prosthetic valve according to any example herein, in particular any one of Examples 22 to 26, wherein the second unit and the third unit have different shapes when the annular frame is in the expanded configuration.

[0295] Example 28. A prosthetic valve according to any example herein, in particular any one of Examples 1 to 27, wherein each support member comprises two arm portions and a joint portion connecting the two arm portions, wherein each support member is configured to fold at the joint portion when the annular frame moves from the expanded configuration to the collapsed configuration.

[0296] Example 29. A prosthetic valve according to any example herein, in particular Example 28, wherein the joint portion of each support member is configured to move axially toward the inflow end when the annular frame moves from the expanded configuration to the collapsed configuration.

[0297] Example 30. A prosthetic valve according to any example herein, in particular Example 28, wherein the joint portion of each support member is configured to move axially toward the outflow end when the annular frame moves from the expanded configuration to the collapsed configuration.

[0298] Example 31. A prosthetic valve comprising: an annular frame that is radially expandable and radially compressible; and an outer skirt disposed on the outer surface of the annular frame, wherein the annular frame comprises: an inflow end; an outflow end; a first row of angled struts and a second row of angled struts, the first row of angled struts defining the outflow end, the second row of angled struts being located upstream of the first row of angled struts; a plurality of axial frame members, the plurality of axial frame members comprising corresponding first and second ends, the first end being connected to the first row of angled struts, and the second end being connected to the second row of angled struts; and a plurality of support members, the plurality of support members connecting the plurality of axial frame members at a connection point located between the first end and the second end, wherein the outer skirt is connected to the support members.

[0299] Example 32. A prosthetic valve according to any example herein, in particular Example 31, further comprising a plurality of leaflets positioned within the annular frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end.

[0300] Example 33. A prosthetic valve according to any example herein, in particular Example 32, wherein the plurality of axial frame members comprises a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support comprises a commissure window configured to accommodate corresponding commissures of two adjacent leaflets.

[0301] Example 34. A prosthetic valve according to any example herein, particularly Example 33, wherein the plurality of axial frame members comprises three axially extending commissure supports and exactly two axial posts located between any two adjacent commissure supports.

[0302] Example 35. A prosthetic valve according to any example herein, in particular any one of Examples 33 to 34, wherein at least some of the support members are connected to the commissure support at a connection point located between the first end and the commissure window.

[0303] Example 36. A prosthetic valve according to any example herein, in particular any one of Examples 33 to 34, wherein at least some of the support members are connected to the commissure support at a connection point located between the second end and the commissure window.

[0304] Example 37. A prosthetic valve according to any example herein, in particular any one of Examples 31 to 36, wherein the support member is narrower than the axial frame member and the first row of angled struts and the second row of angled struts.

[0305] Example 38. A prosthetic valve according to any example herein, in particular any one of Examples 31 to 37, wherein the annular frame further comprises a third row of angled struts upstream of the second row of angled struts and a fourth row of angled struts upstream of the third row of angled struts, wherein the fourth row of angled struts defines the inflow end.

[0306] Example 39. A prosthetic valve according to any example herein, in particular Example 38, wherein the second row of angled struts and the third row of angled struts have the same width, and the first row of angled struts and the fourth row of angled struts have the same width.

[0307] Example 40. A prosthetic valve according to any example herein, in particular any one of Examples 38 to 39, wherein the axial frame member is wider than any of the first row of angled struts, the second row of angled struts, the third row of angled struts, and the fourth row of angled struts.

[0308] Example 41. An annular frame that is radially expandable and radially compressible, the annular frame comprising: an inflow end; an outflow end; an outflow strut row defining the outflow end; an inflow strut row defining the inflow end; an intermediate strut row axially located between the outflow strut row and the inflow strut row; a plurality of axial frame members, the plurality of axial frame members comprising corresponding first and second ends, the first end being connected to the outflow strut row and the second end being connected to the intermediate strut row; and a circumferentially extending row of support members axially located between the outflow strut row and the intermediate strut row, the support members connecting the plurality of axial frame members, wherein each outflow strut comprises two angled strut portions interconnected by a vertex portion, wherein the support member is narrower than the axial frame members, the angled strut portions of the outflow struts, and the struts of the intermediate strut row.

[0309] Example 42. An annular frame according to any example herein, in particular Example 41, wherein the apex portion is narrower than the angled strut portion of the corresponding outflow strut.

[0310] Example 43. An annular frame according to any example herein, in particular any one of Examples 41 to 42, wherein each vertex portion is bent between a pair of two angled strut portions of a corresponding outflow strut.

[0311] Example 44. An annular frame according to any example herein, in particular any one of examples 41 to 43, wherein each vertex portion has an arc length extending along at least 25% of the total arc length of the corresponding outflow strut.

[0312] Example 45. An annular frame according to any example herein, in particular Example 41, wherein each vertex portion forms a U-shaped bend between two angled strut portions of a corresponding outflow strut.

[0313] Example 46. An annular frame according to any example described herein, in particular any one of Examples 41 to 45, wherein each support member comprises two arm portions and a joint portion connecting the two arm portions, wherein when the annular frame expands radially, the two arm portions form an obtuse angle at the joint portion.

[0314] Example 47. An annular frame according to any example herein, in particular Example 46, wherein the joint portion forms a U-shaped bend between the two arm portions.

[0315] Example 48. An annular frame according to any example herein, in particular any one of Examples 46 to 47, wherein the joint portion of each support member is configured to move axially toward the inflow end when the annular frame is radially compressed, and to move axially toward the outflow end when the annular frame is radially expanded.

[0316] Example 49. An annular frame according to any example described herein, in particular any one of Examples 46 to 47, wherein the joint portion of each support member is configured to move axially toward the outflow end when the annular frame is radially compressed, and to move axially toward the inflow end when the annular frame is radially expanded.

[0317] Example 50. An annular frame according to any example herein, in particular any one of examples 46 to 49, wherein each arm portion is substantially straight.

[0318] Example 51. An annular frame according to any example herein, in particular any one of examples 46 to 50, wherein each arm portion is connected to a corresponding axial frame member via a curved attachment portion.

[0319] Example 52. An annular frame according to any example described herein, in particular any one of Examples 46 to 51, wherein each support member is configured to fold at the joint portion when the annular frame is radially compressed so that the two arm portions are substantially parallel to and extend between two adjacent axial frame members.

[0320] Example 53. An annular frame according to any example herein, in particular any one of examples 46 to 52, wherein when the annular frame is radially expanded, the joint portion is closer to the outflow end than the second end of the axial frame member.

[0321] Example 54. An annular frame according to any example herein, in particular Example 53, wherein when the annular frame is radially expanded, the joint portion is axially aligned with the midpoint between the first end and the second end.

[0322] Example 55. An annular frame according to any example herein, in particular any one of examples 41 to 54, wherein the width of the support member ranges from 0.1 mm to 0.3 mm.

[0323] Example 56. An annular frame according to any example herein, in particular Example 55, wherein the width of the support member ranges from 0.18 mm to 0.22 mm.

[0324] Example 57. An annular frame according to any example herein, in particular any one of examples 41 to 56, wherein the width of the angled strut portion of the outflow strut ranges from 0.3 mm to 0.5 mm.

[0325] Example 58. An annular frame according to any example herein, in particular Example 57, wherein the width of the angled strut portion of the outflow strut ranges from 0.38 mm to 0.42 mm.

[0326] Example 59. An annular frame according to any example herein, in particular any one of examples 41 to 58, wherein the width of the struts in the middle strut row ranges from 0.15 mm to 0.35 mm.

[0327] Example 60. An annular frame according to any example herein, in particular Example 59, wherein the width of the struts in the middle strut row ranges from 0.23 mm to 0.27 mm.

[0328] Example 61. An annular frame according to any example herein, in particular any one of examples 41 to 60, wherein the width of the axial frame members ranges from 0.2 mm to 2 mm.

[0329] Example 62. An annular frame according to any example herein, in particular Example 61, wherein the width of the axial frame members ranges from 0.8 mm to 1.2 mm.

[0330] Example 63. An annular frame according to any example herein, in particular any one of examples 41 to 62, wherein the width of the apex portion of the outflow strut ranges from 0.15 mm to 0.25 mm.

[0331] Example 64. An annular frame according to any example herein, in particular Example 63, wherein the width of the apex portion of the outflow strut ranges from 0.18 mm to 0.22 mm.

[0332] Example 65. An annular frame according to any example herein, in particular any one of Examples 41 to 64, wherein the intermediate strut row is a first intermediate strut row, wherein there are one or more additional intermediate strut rows axially located between the first intermediate strut row and the inflow strut row.

[0333] Example 66. An annular frame according to any example herein, in particular Example 65, wherein there are exactly two intermediate strut rows axially located between the outflow strut row and the inflow strut row.

[0334] Example 67. An annular frame according to any example herein, in particular any one of Examples 41 to 66, wherein the plurality of support members are connected to the plurality of axial frame members at a connection point located between the first end and the second end.

[0335] Example 68. An annular frame according to any example herein, in particular Example 67, wherein at least some of the axial frame members include openings.

[0336] Example 69. An annular frame according to any example herein, in particular Example 68, wherein the opening is axially spaced apart from the corresponding connection point.

[0337] Example 70. An annular frame according to any example herein, in particular any one of examples 68 to 69, wherein the axial frame member having the opening is wider than the axial frame member not having the opening.

[0338] Example 71. An annular frame that is radially expandable and radially compressible, the annular frame comprising: a first end row of struts defining a first end of the annular frame; a second end row of struts defining a second end of the annular frame; a plurality of interconnected struts, the plurality of interconnected struts being arranged into one or more rows, the one or more rows extending circumferentially between the first end row of struts and the second end row of struts; a plurality of axial frame members, the plurality of axial frame members comprising corresponding first and second ends, the first end being connected to the first end row of struts, and the second end being connected to the first row of interconnected struts; and a plurality of support members, the plurality of support members connecting the plurality of axial frame members at a connection point axially located between the first end and the second end.

[0339] Example 72. An annular frame according to any example herein, in particular Example 71, wherein the connection point is axially closer to the first end than the midpoint between the first end and the second end.

[0340] Example 73. An annular frame according to any example herein, in particular Example 71, wherein the midpoint between the first end and the second end is axially closer to the first end than the connection point.

[0341] Example 74. An annular frame according to any example herein, in particular any one of Examples 71 to 73, wherein each support member comprises two angled arm portions and a joint portion connecting the two angled arm portions.

[0342] Example 75. An annular frame according to any example herein, in particular Example 74, wherein when the annular frame is radially expanded, the joint portion of the support member is axially closer to the second end than the connection point.

[0343] Example 76. An annular frame according to any example herein, in particular Example 74, wherein when the annular frame is radially expanded, the joint portion of the support member is axially closer to the first end than the connection point.

[0344] Example 77. An annular frame according to any example herein, in particular any one of Examples 74 to 76, wherein when the annular frame is radially expanded, the joint portion of the support member is axially located between the first end and the second end of the axial frame member.

[0345] Example 78. An annular frame according to any example herein, in particular any one of examples 74 to 76, wherein the joint portion is axially aligned with the first end of the axial frame member when the annular frame is radially expanded.

[0346] Example 79. An annular frame according to any example herein, in particular any one of examples 74 to 78, wherein when the annular frame is radially expanded, the axial distance between the second end and the joint portion is at least 10 mm.

[0347] Example 80. An annular frame according to any example herein, in particular Example 79, wherein when the annular frame expands radially, the axial distance between the second end and the joint portion is one third to two half of the height of the annular frame, wherein the height of the annular frame is measured between the first end and the second end.

[0348] Example 81. An annular frame according to any example herein, in particular any one of Examples 71 to 80, wherein each first end strut comprises two angled strut portions interconnected by a vertex portion.

[0349] Example 82. An annular frame according to any example herein, in particular Example 81, wherein the support member is narrower than the axial frame member and the angled strut portion of the first end strut.

[0350] Example 83. An annular frame according to any example herein, in particular any one of examples 71 to 92, wherein the support member comprises a fully annealed metal.

[0351] Example 84. An annular frame according to any example herein, in particular any one of examples 71 to 83, wherein there is exactly one circumferentially extending row of interconnecting struts connecting the second ends of the plurality of axial frame members.

[0352] Example 85. An assembly comprising: a prosthetic device including a frame and a delivery device, the prosthetic device being movable between a radially expanded state and a radially compressed state, the delivery device being configured to deliver the prosthetic device in a radially compressed state to a target location; wherein the frame comprises: an outflow strut row defining an outflow end of the frame; an inflow strut row defining an inflow end of the frame; an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row; a plurality of axial frame members comprising respective first and second ends, the first end being connected to the outflow strut row and the second end being connected to the interconnected strut row; and a plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row, wherein each outflow strut comprises two angled strut portions interconnected by a vertex portion, wherein the support member is narrower than the axial frame members, the angled strut portions of the outflow struts, and the interconnected strut rows.

[0353] Example 86. An assembly according to any example herein, in particular Example 85, wherein the plurality of support members are connected to the plurality of axial frame members at a connection point axially located between the first end and the second end.

[0354] Example 87. An assembly according to any example herein, in particular any one of Examples 85 to 86, wherein the prosthetic device further includes a leaflet structure positioned within the frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end.

[0355] Example 88. An assembly according to any example herein, in particular Example 87, wherein the plurality of axial frame members comprises a plurality of commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support is configured to support a corresponding commissure of the leaflet structure.

[0356] Example 89. An assembly according to any example herein, in particular any one of Examples 85 to 88, wherein the prosthetic device further includes an outer skirt disposed on an outer surface of the frame, wherein the outer skirt is connected to the support member.

[0357] Example 90. An assembly according to any example herein, in particular Example 89, wherein the outer skirt extends from the inflow end of the frame to an outflow edge of the outer skirt, wherein the outflow edge of the outer skirt is axially closer to the outflow end of the frame than the second end of the axial frame member.

[0358] Example 91. An assembly according to any example herein, particularly Example 90, wherein the outflow edge of the outer skirt is located axially between the first end and the second end of the axial frame member.

[0359] Example 92. An assembly according to any example herein, in particular example 90, wherein the outflow edge of the outer skirt is axially aligned with the first end of the axial frame member.

[0360] Example 93. An assembly according to any example herein, in particular any one of Examples 85 to 92, wherein the delivery device comprises a balloon shaft and a balloon mounted on a distal portion of the balloon shaft, wherein the prosthetic device is curled on the balloon when the prosthetic device is delivered to the target location.

[0361] Example 94. An assembly according to any example herein, in particular any one of Examples 85 to 92, wherein the prosthetic device is self-expandable from a radially compressed state to a radially expanded state, wherein the delivery device includes an outer sheath configured to maintain the prosthetic device in the radially compressed state when the prosthetic device is delivered to the target location.

[0362] Example 95. An assembly according to any example herein, in particular any one of Examples 85 to 92, wherein the delivery device includes an actuator connected to an expansion mechanism of the frame, wherein actuation of the actuator is configured to radially expand the prosthetic device from the radially compressed state to the radially expanded state.

[0363] Example 96. A method for assembling a prosthetic device, the method comprising: preparing an annular frame, the annular frame comprising: an outflow strut row defining an outflow end of the annular frame; an inflow strut row defining an inflow end of the annular frame; an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row; and a plurality of axial frame members, the plurality of axial frame members comprising corresponding first and second ends, the first ends being connected to the outflow strut row and the second ends being connected to the interconnected strut row; and bridging the plurality of axial frame members and a plurality of support members so that the support members extend circumferentially between the outflow strut row and the interconnected strut row, wherein each outflow strut comprises two angled strut portions interconnected by a vertex portion, wherein the support member is narrower than the axial frame members, the angled strut portions of the outflow struts, and the interconnected strut rows.

[0364] Example 97. A method according to any example herein, in particular Example 96, wherein the bridging includes connecting the plurality of support members to the plurality of axial frame members at a connection point axially located between the first end and the second end.

[0365] Example 98. A method according to any example herein, in particular any one of Examples 96 to 97, further comprising attaching a leaflet structure to the annular frame, wherein the leaflet structure is configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end.

[0366] Example 99. A method according to any example herein, in particular Example 98, wherein attaching the leaflet structure to the annular frame includes connecting the leaflet structure to an inner skirt and attaching the inner skirt to an inner surface of the annular frame.

[0367] Example 100. A method according to any example described herein, in particular any one of Examples 98 to 99, wherein attaching the leaflet structure to the annular frame includes attaching a plurality of commissures of the leaflet structure to corresponding commissure supports of the annular frame, wherein the commissure supports are selected components of the axial frame component.

[0368] Example 101. A method according to any example herein, in particular any one of Examples 96 to 100, further comprising attaching an outer skirt to the outer surface of the annular frame.

[0369] Example 102. A method according to any example herein, in particular Example 101, wherein attaching the outer skirt to the outer surface of the annular frame includes attaching an outflow edge portion of the outer skirt to the plurality of support members.

[0370] Example 103. A method according to any example herein, in particular any one of Examples 101 to 102, wherein attaching the outer skirt to the outer surface of the annular frame includes attaching the outflow edge portion of the outer skirt to the axial frame member.

[0371] Example 104. The method according to any example herein, in particular any one of examples 96 to 103, further comprising fully annealing the plurality of support members.

[0372] Example 105. A method for assembling a prosthetic device, the method comprising: preparing an annular frame, the annular frame comprising: an outflow strut row defining an outflow end of the annular frame; an inflow strut row defining an inflow end of the annular frame; an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row; a plurality of axial frame members, the plurality of axial frame members comprising respective first and second ends, the first ends being connected to the outflow strut row and the second ends being connected to the interconnected strut row; and a plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row; and attaching an outflow skirt to an outer surface of the annular frame, wherein the attachment comprises connecting an outflow edge portion of the outer skirt to the plurality of support members; wherein each outflow strut comprises two angled strut portions interconnected by an apex portion, wherein the support member is narrower than the axial frame members, the angled strut portions of the outflow struts, and the interconnected strut rows.

[0373] Example 106. A method comprising: delivering a prosthetic device in a radially compressed state to a target location; and radially expanding the prosthetic device to a radially expanded state, wherein the prosthetic device comprises a radially expandable and radially compressible frame, wherein the frame comprises: an outflow strut row defining an outflow end of the frame; an inflow strut row defining an inflow end of the frame; an interconnected strut row extending circumferentially between the outflow strut row and the inflow strut row; a plurality of axial frame members, the plurality of axial frame members comprising respective first and second ends, the first end being connected to the outflow strut row and the second end being connected to the interconnected strut row; and a plurality of support members connecting the plurality of axial frame members and extending between the outflow strut row and the interconnected strut row, wherein each outflow strut comprises two angled strut portions interconnected by an apex portion, wherein the support member is narrower than the axial frame members, the angled strut portions of the outflow struts, and the interconnected strut rows.

[0374] Example 107. A prosthetic valve comprising: an annular frame movable between a radially compressed configuration and a radially expanded configuration, wherein the frame has an inflow end and an outflow end; and a leaflet structure positioned within the frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end, wherein the frame comprises: a first row of angled struts defining the outflow end; a second row of angled struts located upstream of the first row of angled struts; a third row of angled struts located upstream of the second row of angled struts; and a plurality of axial frame members comprising respective first and second ends, the first end being connected to the second row of angled struts and the second end being connected to the third row of angled struts; wherein the plurality of axial frame members comprise a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support is configured to support a corresponding commissure of the leaflet structure.

[0375] Example 108. The prosthetic valve of any example herein, particularly Example 107, wherein there are two or more angled struts in the second row connecting each pair of adjacent axial frame members.

[0376] Example 109. A prosthetic valve according to any example described herein, in particular any one of Examples 107 to 108, wherein the second row of angled struts are joined together at alternating upper and lower ends, wherein the upper ends are axially located between the lower end and the outflow end, wherein the first row of angled struts connects the second row of angled struts at the upper ends, and wherein the plurality of axial frame members are connected to the lower end.

[0377] Example 110. A prosthetic valve according to any example described herein, in particular any one of Examples 107 to 108, wherein the second row of angled struts are joined together at alternating upper and lower ends, wherein the upper ends are axially located between the lower ends and the outflow end, wherein the first row of angled struts connects the second row of angled struts at the upper ends, and wherein the plurality of axial frame members are connected to the upper ends.

[0378] Example 111. A prosthetic valve according to any example herein, in particular any one of Examples 107 to 110, wherein the first row of angled struts is narrower than the second row of angled struts.

[0379] Example 112. A prosthetic valve according to any example herein, in particular any one of Examples 107 to 111, wherein the second row of angled struts is wider than the third row of angled struts.

[0380] Example 113. A prosthetic valve according to any example described herein, in particular any one of Examples 107 to 112, wherein the first row of angled struts and the second row of angled struts define a plurality of first units of the frame, wherein the second row of angled struts, the third row of angled struts, and the plurality of axial frame members define a plurality of second units of the frame, wherein when the frame is in the radially expanded configuration, the first units are smaller than the second units.

[0381] Example 114. A prosthetic valve according to any example herein, in particular Example 113, wherein the first unit has a diamond shape when the frame is in the radially expanded configuration.

[0382] Example 115. A prosthetic valve according to any example herein, in particular any one of Examples 113 to 114, wherein the number of the first units and the number of the second units have a ratio of 1:1.

[0383] Example 116. A prosthetic valve according to any example herein, in particular any one of Examples 113 to 114, wherein the number of first units and the number of second units have a ratio of M:1, wherein M is greater than 1.

[0384] Example 117. A prosthetic valve according to any example herein, in particular Example 116, wherein M is equal to 2.

[0385] Example 118. A prosthetic valve according to any example herein, in particular any one of Examples 113 to 117, wherein the number of second units is 9.

[0386] Example 119. A prosthetic valve according to any example herein, in particular any one of Examples 113 to 118, further comprising a fourth row of angled struts located upstream of the third row of angled struts, wherein the third row of angled struts and the fourth row of angled struts define a plurality of third units of the frame, wherein the third units are smaller than the second units when the frame is in the radially expanded configuration.

[0387] Example 120. A prosthetic valve according to any example herein, in particular Example 119, wherein the third cell is larger than the first cell when the frame is in the radially expanded configuration.

[0388] Example 121. A prosthetic valve according to any example herein, in particular any one of Examples 119 to 120, wherein the number of second units is equal to the number of third units.

[0389] Example 122. A prosthetic valve according to any example herein, particularly any one of Examples 119 to 121, further comprising a fifth row of angled struts upstream of the fourth row of angled struts, wherein the fifth row of angled struts defines the inflow end.

[0390] Example 123. A prosthetic valve according to any example described herein, in particular any one of Examples 107 to 114, wherein each of the first row of angled struts and the second row of angled struts comprises at least four or more angled struts extending between adjacent axial frame members.

[0391] Example 124. A prosthetic valve comprising: an annular frame movable between a radially compressed configuration and a radially expanded configuration, wherein the frame has an inflow end and an outflow end; and a leaflet structure positioned within the frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end, wherein the frame comprises: a first row of angled struts defining the outflow end; a second row of angled struts located upstream of the first row of angled struts; a third row of angled struts located upstream of the second row of angled struts; a fourth row of angled struts located upstream of the third row of angled struts; and a plurality of axial frame members, the plurality of axial frame members comprising respective first and second ends, the first end being connected to the second row of angled struts, and the second end being connected to the third row of angled struts; wherein the first row of angled struts and the second row of angled struts define a plurality of first units of the frame, wherein the second row of angled struts, the third row of angled struts, and the plurality of axial frame members define a plurality of second units of the frame, wherein the third row of angled struts and the fourth row of angled struts define a plurality of third units of the frame, wherein the number of first units is greater than the number of second units, and wherein the number of second units is equal to the number of third units.

[0392] Example 125. A prosthetic valve according to any example herein, in particular Example 124, wherein the plurality of axial frame members comprises a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support is configured to support a corresponding commissure of the leaflet structure.

[0393] Example 126. A prosthetic valve according to any example herein, in particular any one of Examples 124 to 125, wherein the number of first units is 18 and the number of second units is 9.

[0394] Example 127. A prosthetic valve according to any example herein, in particular any one of Examples 124 to 126, wherein when the frame is in the radially expanded configuration, the first unit is smaller than the third unit, and the third unit is smaller than the second unit.

[0395] Example 128. An annular frame movable between a radially compressed configuration and a radially expanded configuration, the annular frame comprising: a first row of angled struts defining the outflow end; a second row of angled struts located upstream of the first row of angled struts; a third row of angled struts located upstream of the second row of angled struts; a fourth row of angled struts located upstream of the third row of angled struts; and a plurality of axial frame members comprising respective first and second ends, the first end connected to the second row of angled struts, and the second end connected to the third row of angled struts; wherein the first row of angled struts and the second row of angled struts define a plurality of first units of the frame, wherein the second row of angled struts, the third row of angled struts and the plurality of axial frame members define a plurality of second units of the frame, wherein the third row of angled struts and the fourth row of angled struts define a plurality of third units of the frame, wherein when the frame is in the radially expanded configuration, the first unit is smaller than the third unit, and the third unit is smaller than the second unit.

[0396] Example 129. An annular frame according to any example herein, in particular Example 128, wherein the number of first units is a multiple of the number of second units, wherein the number of second units is equal to the number of third units.

[0397] Example 130. An annular frame according to any example herein, in particular any one of Examples 128 to 129, wherein the first row of angled struts forms a plurality of arcs when the frame is in the radially expanded configuration.

[0398] Example 131. An annular frame according to any example described herein, in particular any one of Examples 128 to 130, wherein the plurality of axial frame members comprises a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support is configured to support a corresponding commissure of a leaflet structure mounted within the annular frame.

[0399] Example 132. A prosthetic valve comprising: an annular frame movable between a radially compressed configuration and a radially expanded configuration, wherein the frame has an inflow end and an outflow end; and a leaflet structure positioned within the frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end, wherein the frame comprises: a first row of angled struts defining the outflow end; a second row of angled struts upstream of the first row of angled struts; a third row of angled struts upstream of the second row of angled struts struts; a plurality of axial frame members, said plurality of axial frame members bridging said second row of angled struts and said third row of angled struts; wherein said plurality of axial frame members comprise a plurality of axially extending joint supports and one or more axial columns located between any two adjacent joint supports, wherein said second row of angled struts, said third row of angled struts and said plurality of axial frame members define a plurality of outflow units, wherein said frame further comprises one or more axial support struts, said one or more axial support struts dividing at least some of said outflow units into two.

[0400] Example 133. A prosthetic valve according to any example herein, in particular Example 132, wherein the one or more axial support struts are narrower than the plurality of axial frame members.

[0401] Example 134. A prosthetic valve according to any example herein, in particular any of Examples 132 to 133, wherein the one or more axial support struts are longer than the plurality of axial frame members.

[0402] Example 135. A prosthetic valve comprising a frame comprising: an inflow end; an outflow end; an outflow strut row defining the outflow end; an inflow strut row defining the inflow end; an intermediate strut row axially located between the outflow strut row and the inflow strut row; a plurality of axial frame members comprising respective first and second ends, the first ends being connected to the outflow strut row and the second ends being connected to the intermediate strut row; and a circumferentially extending row of support members axially located between the outflow strut row and the intermediate strut row, the support members connecting the plurality of axial frame members, wherein each outflow strut comprises two angled strut portions interconnected by an apex portion; a plurality of axial support struts having a first end connected to a respective apex portion of the outflow strut and a second end connected to a respective joint portion of the support member.

[0403] Example 136. A prosthetic valve according to any example herein, particularly Example 135, wherein the support member is narrower than the axial frame member, the angled strut portions of the outflow struts, and the struts of the intermediate strut row.

[0404] Example 137. A prosthetic valve comprising: an annular frame that is radially expandable and radially compressible; and wherein the annular frame comprises: an outflow strut row defining an outflow end of the frame; an inflow strut row defining an inflow end of the frame; an intermediate row of angled struts axially located between the outflow strut row and the inflow strut row; a plurality of axial frame members that bridge the outflow strut row and the intermediate row of angled struts; and a plurality of support structures that connect the plurality of axial frame members and the intermediate row of angled struts, wherein each support structure comprises at least two angled support arms connecting two adjacent axial frame members and at least one axial support member that bridges the at least two angled support arms and the intermediate row of angled struts.

[0405] Example 138. A prosthetic valve according to any example herein, particularly Example 137, wherein the angled support arms are narrower than the outflow struts and the inflow struts.

[0406] Example 139. A prosthetic valve according to any example herein, in particular any one of Examples 137 to 138, wherein the axial support member is narrower than the axial frame member.

[0407] Example 140. A prosthetic valve according to any example herein, in particular any one of Examples 137 to 139, wherein the angled support arms are narrower than the axial support member.

[0408] Example 141. A prosthetic valve according to any of the examples described herein, in particular any of Examples 137 to 140, wherein each axial frame member comprises a first end connected to the outflow row of struts, a second end connected to the angled struts of the intermediate row, and a connection point wherein two angled support arms of two adjacent support structures located on either side of the axial frame member are connected to the axial frame member.

[0409] Example 142. A prosthetic valve according to any example herein, in particular Example 141, wherein for each axial frame member, the first end is the connection point.

[0410] Example 143. A prosthetic valve according to any example herein, in particular Example 141, wherein for each axial frame member, the connection point is axially spaced from the first end.

[0411] Example 144. A prosthetic valve according to any example herein, in particular Example 143, wherein for each axial frame member, the connection point is closer to the first end than the second end.

[0412] Example 145. A prosthetic valve according to any example herein, in particular any one of Examples 137 to 144, further comprising an outer skirt disposed on an outer surface of the annular frame, wherein the outer skirt is attached to the angled support arm of each support structure.

[0413] Example 146. A prosthetic valve according to any example described herein, in particular any one of Examples 137 to 145, wherein each support structure comprises exactly two angled support arms and exactly one axial support member, wherein the two angled support arms and the one axial support member define a Y-shaped configuration.

[0414] Example 147. A prosthetic valve according to any example herein, in particular Example 146, wherein the middle row of angled struts are joined together at alternating upper and lower ends, the upper ends being closer to the outflow end than the lower ends, and wherein the axial support members of the support structure are connected to the corresponding lower ends of the middle row of angled struts.

[0415] Example 148. A prosthetic valve according to any example herein, in particular Example 147, wherein the outflow strut rows, the intermediate row of angled struts, and the plurality of axial frame members define a plurality of outflow units, wherein each support structure divides the corresponding outflow unit into three subunits.

[0416] Example 149. A prosthetic valve according to any example herein, in particular Example 148, wherein the three subunits include an upper subunit and two lower subunits, wherein the width of the upper subunit is twice the width of each lower subunit.

[0417] Example 150. A prosthetic valve according to any example herein, in particular any one of Examples 148 to 149, wherein the upper subunit is six-sided or four-sided.

[0418] Example 151. A prosthetic valve according to any example herein, in particular any one of Examples 148 to 150, wherein each of the lower subunits has a parallelogram shape.

[0419] Example 152. A prosthetic valve according to any example herein, particularly any one of Examples 146 to 151, wherein the intermediate row of angled struts is the only row of angled struts extending between the outflow strut row and the inflow strut row.

[0420] Example 153. A prosthetic valve according to any example described herein, in particular any one of Examples 146 to 151, wherein the intermediate row of angled struts is a first intermediate row of angled struts, wherein there are one or more additional intermediate rows of angled struts located between the first intermediate row of angled struts and the row of inflow struts.

[0421] Example 154. A prosthetic valve according to any example herein, in particular Example 153, wherein there are exactly two intermediate rows of angled struts located between the outflow strut row and the inflow strut row.

[0422] Example 155. A prosthetic valve according to any example herein, in particular Example 153, wherein there are exactly three intermediate rows of angled struts located between the outflow strut row and the inflow strut row.

[0423] Example 156. A prosthetic valve according to any example herein, in particular any one of Examples 146 to 151, wherein the axial support members of the support structure terminate at corresponding lower ends of the middle row of angled struts.

[0424] Example 157. A prosthetic valve according to any example herein, in particular any one of Examples 146 to 151, wherein the axial support member of the support structure further bridges the intermediate row of angled struts and the inflow strut row.

[0425] Example 158. A prosthetic valve according to any example herein, in particular Example 157, wherein the row of inflow struts defines a plurality of upper ends downstream of the inflow end, wherein the axial support member of the support structure connects the lower ends of the angled struts of the intermediate row to the corresponding upper ends of the row of inflow struts.

[0426] Example 159. A prosthetic valve according to any example herein, in particular Example 158, wherein the number of vertices defined by the outflow struts and the number of vertices defined by the inflow struts have a ratio of 1:2.

[0427] Example 160. A prosthetic valve according to any example described herein, in particular any one of Examples 146 to 151, wherein the plurality of support structures are first support structures, wherein the annular frame further comprises a plurality of second support structures, wherein each second support structure comprises two angled support arms defining an inverted Y-shaped configuration and an axial support member.

[0428] Example 161. A prosthetic valve according to any of the examples herein, in particular Example 160, wherein the middle row of angled struts is a first middle row of angled struts and the plurality of axial frame members are first axial frame members, wherein the annular frame further includes a second middle row of angled struts upstream of the first middle row of angled struts and a plurality of second axial frame members bridging the second middle row of angled struts and the row of inflow struts.

[0429] Example 162. A prosthetic valve according to any of the examples herein, in particular Example 161, wherein the axial support member of the first support structure is connected to the axial support member of the second support structure at a junction between the angled struts of the first middle row and the angled struts of the second middle row, such that each first support structure is a mirror image of the corresponding second support structure.

[0430] Example 163. A prosthetic valve according to any example described herein, in particular any one of Examples 161 to 162, wherein for each second support structure, the two angled support arms connect two adjacent second axial frame members, and the axial support member bridges the two angled support arms and the second intermediate row of angled struts.

[0431] Example 164. A prosthetic valve according to any example described herein, in particular any one of Examples 137 to 144, wherein each support structure comprises exactly four angled support arms, the four angled support arms being interconnected to define a W-shaped configuration, wherein the four angled support arms comprise two side support arms respectively connected to two adjacent axial frame members and two intermediate support arms positioned between the two side support arms.

[0432] Example 165. A prosthetic valve according to any example herein, in particular Example 164, wherein there are exactly six axial frame members.

[0433] Example 166. A prosthetic valve according to any example described herein, in particular any one of Examples 164 to 165, wherein the intermediate rows of angled struts are joined together at alternating upper and lower ends, wherein each support structure includes an intermediate axial support member connecting the joint of the two intermediate support arms and the corresponding upper ends of the intermediate rows of angled struts.

[0434] Example 167. A prosthetic valve according to any example herein, in particular Example 166, wherein the outflow strut row, the intermediate row of angled struts, and the plurality of axial frame members define a plurality of outflow units, wherein each support structure divides the corresponding outflow unit into an upper subunit and two lower subunits.

[0435] Example 168. A prosthetic valve according to any example herein, in particular Example 167, wherein each lower subunit is six-sided and the width of the upper subunit is twice the width of each lower subunit.

[0436] Example 169. A prosthetic valve according to any of the examples herein, in particular Example 166, wherein each support structure further comprises two lateral axial support members located on opposite sides of the intermediate support member, wherein each lateral axial support member connects one of the lower ends of the intermediate row of angled struts and a joint formed between the lateral support arm and an adjacent intermediate support arm.

[0437] Example 170. A prosthetic valve according to any example herein, in particular Example 169, wherein the outflow strut row, the intermediate row of angled struts, and the plurality of axial frame members define a plurality of outflow units, wherein each support structure divides the corresponding outflow unit into an upper subunit and four lower subunits.

[0438] Example 171. A prosthetic valve according to any example herein, in particular Example 170, wherein the width of each of the lower subunits is one quarter the width of the upper subunit.

[0439] Example 172. A prosthetic valve according to any example herein, in particular any one of Examples 170 to 171, wherein each of the lower subunits has a parallelogram shape.

[0440] Example 173. A prosthetic valve comprising: an annular frame that is radially expandable and radially compressible, wherein the annular frame comprises: an outflow strut row defining an outflow end of the frame; an inflow strut row defining an inflow end of the frame; a first intermediate row of angled struts and a second intermediate row of angled struts axially located between the outflow strut row and the inflow strut row, the second intermediate row of angled struts being located upstream of the first intermediate row of angled struts; a plurality of axial frame members that bridge the outflow strut row and the first intermediate row of angled struts; and a plurality of support structures that connect the plurality of axial frame members and the first intermediate row of angled struts and the second intermediate row of angled struts, wherein each support structure comprises at least two angled support arms connecting two adjacent axial frame members and two or more axial support members that bridge the at least two angled support arms and the first intermediate row of angled struts and the second intermediate row of angled struts.

[0441] Example 174. A prosthetic valve according to any example herein, particularly Example 173, wherein the angled support arms are narrower than the outflow struts and the inflow struts.

[0442] Example 175. A prosthetic valve according to any example herein, in particular any of Examples 173 to 174, wherein the axial support member is narrower than the axial frame member.

[0443] Example 176. A prosthetic valve according to any example herein, in particular any one of Examples 173 to 175, further comprising an outer skirt disposed on an outer surface of the annular frame, wherein the outer skirt is connected to at least a portion of the support structure.

[0444] Example 177. A prosthetic valve according to any of the examples described herein, in particular any of Examples 173 to 176, wherein each axial frame member comprises a first end connected to the outflow row of struts, a second end connected to the angled struts of the first intermediate row, and a connection point wherein two angled support arms of two adjacent support structures located on either side of the axial frame member are connected to the axial frame member.

[0445] Example 178. The prosthetic valve of any example herein, particularly Example 177, wherein for each axial frame member, the first end is the connection point.

[0446] Example 179. The prosthetic valve of any example herein, particularly Example 177, wherein for each axial frame member, the connection point is axially spaced from the first end.

[0447] Example 180. A prosthetic valve according to any of the examples described herein, in particular any of Examples 177 to 179, wherein the second end of each axial frame member is connected to two angled struts in the first middle row of angled struts, and the two angled struts are not directly connected to any other angled struts in the first middle row of angled struts.

[0448] Example 181. A prosthetic valve according to any example herein, in particular any one of Examples 177 to 180, wherein the second middle row of angled struts are joined together at alternating upper and lower ends, wherein each angled strut in the first middle row of angled struts is connected to one of the upper ends of the second middle row of angled struts.

[0449] Example 182. A prosthetic valve according to any example herein, in particular Example 181, wherein each support structure comprises exactly two angled support arms, an intermediate axial support member and two side axial support members, wherein the intermediate axial support member has an upper end connected to a joint of the two angled support arms, and wherein the two side axial support members have corresponding upper ends connected to corresponding midpoints of the two angled support arms.

[0450] Example 183. A prosthetic valve according to any example herein, in particular Example 182, wherein each support structure further comprises a connecting support member connecting the midpoints of the two angled support arms.

[0451] Example 184. A prosthetic valve according to any example herein, in particular any one of Examples 182 to 183, wherein for each support structure, the intermediate axial support member has a lower end connected to one of the lower ends of the second intermediate row of angled struts, and wherein the two side axial support members have corresponding lower ends connected to corresponding upper ends of the second intermediate row of angled struts.

[0452] Example 185. A prosthetic valve according to any example described herein, in particular any one of Examples 182 to 184, wherein the outflow strut row, the first middle row of angled struts, the second middle row of angled struts, and the plurality of axial frame members define a plurality of outflow units, wherein each support structure divides the corresponding outflow unit into a plurality of sub-units, wherein the plurality of sub-units comprises a row of four sub-units, each of the sub-units having a parallelogram shape.

[0453] Example 186. A prosthetic valve according to any of the examples herein, in particular Example 181, wherein each support structure comprises eight angled support arms and four axial support members, wherein each axial support member has an upper end connected to corresponding joints of two angled support arms and a lower end connected to a corresponding upper end of the second middle row of angled struts.

[0454] Example 187. A prosthetic valve according to any of the examples herein, in particular Example 186, wherein the outflow strut row, the first middle row of angled struts, the second middle row of angled struts, and the plurality of axial frame members define a plurality of outflow units, wherein each support structure divides the corresponding outflow unit into a plurality of sub-units, wherein the plurality of sub-units comprises a row of five sub-units, wherein the row of five sub-units comprises three hexahedral sub-units located between two parallelogram sub-units.

[0455] Example 188. A method comprising sterilizing a prosthetic valve, frame, and / or assembly according to any example herein, particularly any one of Examples 1-95 and 107-187.

[0456] Unless otherwise stated, the features described herein with respect to any example may be combined with other features described in any one or more examples in other examples. For example, any one or more features of the features of one frame or prosthetic valve may be combined with any one or more features of another frame or prosthetic valve.

[0457] In view of the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated examples are merely preferred examples of the technology and should not be taken as limiting the scope of the disclosure. Instead, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A prosthetic valve, comprising: an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration; and an outer skirt, the outer skirt being disposed on an outer surface of the annular frame, The annular frame comprises: Inflow end; outflow end; a first row of angled struts, the first row of angled struts defining the outflow end; a second row of angled struts, the second row of angled struts being closer to the inflow end than the first row of angled struts; a plurality of axial frame members bridging the first row of angled struts and the second row of angled struts; as well as a plurality of support members connecting the plurality of axial frame members, wherein the support member is narrower than the axial frame member and the first row of angled struts and the second row of angled struts, Wherein the outer skirt is connected to the support member.

2. The prosthetic valve of claim 1, wherein the annular frame comprises at least four rows of angled struts.

3. A prosthetic valve according to any one of claims 1 to 2, wherein each support member comprises two arm portions and a joint portion connecting the two arm portions, wherein each support member is configured to fold at the joint portion when the annular frame moves from the expanded configuration to the collapsed configuration.

4. The prosthetic valve of claim 3, wherein the joint portion of each support member is configured to move axially toward the inflow end when the annular frame moves from the expanded configuration to the collapsed configuration.

5. The prosthetic valve of claim 4, wherein the joint portion of each support member is configured to move axially toward the outflow end when the annular frame moves from the expanded configuration to the collapsed configuration.

6. A prosthetic valve, comprising: an annular frame that is radially expandable and radially compressible; and an outer skirt, the outer skirt being disposed on an outer surface of the annular frame, The annular frame comprises: Inflow end; outflow end; a first row of angled struts defining the outflow end and a second row of angled struts located upstream of the first row of angled struts; a plurality of axial frame members, the plurality of axial frame members comprising respective first and second ends, the first ends connected to the first row of angled struts and the second ends connected to the second row of angled struts; as well as a plurality of support members connecting the plurality of axial frame members at connection points between the first end and the second end, Wherein the outer skirt is connected to the support member.

7. The prosthetic valve of claim 6, further comprising a plurality of leaflets positioned within the annular frame and configured to allow blood to flow from the inflow end to the outflow end and to prevent blood from flowing from the outflow end to the inflow end.

8. A prosthetic valve according to claim 7, wherein the plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial columns located between any two adjacent commissure supports, wherein each commissure support includes a commissure window configured to accommodate corresponding commissures of two adjacent leaflets.

9. The prosthetic valve of claim 8, wherein the plurality of axial frame members comprises three axially extending commissure supports and exactly two axial posts located between any two immediately adjacent commissure supports.

10. The prosthetic valve of any one of claims 8 to 9, wherein at least some of the support members are connected to the commissure supports at connection points located between the first end and the commissure windows.

11. The prosthetic valve of any one of claims 8 to 9, wherein at least some of the support members are connected to the commissure supports at connection points located between the second end and the commissure windows.

12. The prosthetic valve of any one of claims 6 to 11, wherein the support member is narrower than the axial frame member and the first and second rows of angled struts.

13. A prosthetic valve according to any one of claims 6 to 12, wherein the annular frame further includes a third row of angled struts located upstream of the second row of angled struts and a fourth row of angled struts located upstream of the third row of angled struts, wherein the fourth row of angled struts defines the inflow end.

14. The prosthetic valve of claim 13, wherein the second row of angled struts and the third row of angled struts have the same width, and the first row of angled struts and the fourth row of angled struts have the same width.

15. The prosthetic valve of any one of claims 13 to 14, wherein the axial frame member is wider than any of the first row of angled struts, the second row of angled struts, the third row of angled struts, and the fourth row of angled struts.

16. An annular frame, which is radially expandable and radially compressible, comprising: a first end strut row, the first end strut row defining a first end of the annular frame; a second end strut row defining a second end of the annular frame; a plurality of interconnected struts arranged in one or more rows extending circumferentially between the first end strut row and the second end strut row; a plurality of axial frame members including respective first and second ends, the first ends connected to the first row of end struts and the second ends connected to the first row of interconnecting struts; as well as A plurality of support members connect the plurality of axial frame members at a connection point axially between the first end and the second end.

17. The annular frame of claim 16, wherein the connection point is axially closer to the first end than a midpoint between the first end and the second end.

18. The annular frame of claim 16, wherein a midpoint between the first end and the second end is axially closer to the first end than the connection point.

19. The annular frame according to any one of claims 16 to 18, wherein each support member comprises two angled arm portions and a joint portion connecting the two angled arm portions.

20. The annular frame of claim 19, wherein the joint portion of the support member is axially closer to the second end than the connection point when the annular frame is radially expanded.

21. The annular frame of claim 19, wherein the joint portion of the support member is axially closer to the first end than the connection point when the annular frame is radially expanded.

22. An annular frame according to any one of claims 19 to 21, wherein the joint portion of the support member is axially located between the first and second ends of the axial frame member when the annular frame is radially expanded.

23. An annular frame according to any one of claims 19 to 21, wherein the joint portion is axially aligned with the first end of the axial frame member when the annular frame is radially expanded.

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