Artificial valve with steps of support members

Abstract

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

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 343,986, filed May 19, 2022, and U.S. Provisional Application No. 63 / 422,349, filed November 3, 2022, both of which are incorporated by reference herein.

[0002] 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 technology]

[0003] The human heart can suffer from a variety of valvular diseases, which can cause serious malfunctions of the heart, ultimately requiring repair of the natural valve or replacement of the natural valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting the devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in a variety of procedures to deliver artificial medical devices to locations within the body that are not easily accessible by surgery or where access without surgery is desirable. In one embodiment, an artificial heart valve (or simply an "artificial valve") can be mounted in a compressed state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, or by actuating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of a delivery device, allowing the prosthetic valve to self-expand to its functional size.

[0004] The prosthetic valve can include a radially compressible and expandable frame and a leaflet structure mounted within the frame. In some circumstances, the prosthetic valve can have a sealing member, such as an outer skirt, mounted on an outer surface of the frame. The outer skirt can be configured to seal against surrounding native tissue to reduce paravalvular leakage through the prosthetic valve.

[0005] Despite recent advances in percutaneous valve technology, there remains a need for improvements in transcatheter prosthetic valves, such as improving frame strength and reducing paravalvular leakage. Summary of the Invention

[0006] 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.

[0007] 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 components disclosed herein.

[0008] In some examples, the frame of the 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 located closer to the inflow end compared to 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.

[0009] In some examples, the frame of the prosthetic valve can include multiple support members connecting multiple axial frame members.

[0010] In some examples, the support members may be narrower in width compared to the axial frame members, compared to the first row of diagonal struts, and compared to the second row of diagonal struts.

[0011] In some examples, the frame of the prosthetic valve can include a plurality of axial frame members each including a corresponding first end and a second end, the first ends connected to a first row of oblique struts and the second ends connected to a second row of oblique struts.

[0012] In some examples, the frame of the prosthetic valve can include a plurality of support members connecting the plurality of axial frame members at connection points located between the first and second ends of the axial frame members.

[0013] In some instances, the prosthetic valve can include an outer skirt disposed on an outer surface of the frame.

[0014] In some examples, the outer skirt may be connected to a support member.

[0015] In some examples, the frame of the prosthetic valve can include a first row of oblique struts defining an outflow end, a second row of oblique struts located upstream from the first row of oblique struts, a third row of oblique struts located upstream from the second row of oblique struts, and a plurality of axial frame members having corresponding first and second ends, the first ends connected to the second row of oblique struts and the second ends connected to the third row of oblique struts.

[0016] In some examples, the plurality of axial frame members can include a plurality of axially extending commissural supports and one or more axial posts located between every two immediately adjacent commissural supports, each commissural support configured to support a corresponding commissure of a leaflet structure within the prosthetic valve.

[0017] In some instances, the frame of the prosthetic valve can further include a fourth row of angled struts located upstream from the third row of angled struts.

[0018] In some examples, the first row of diagonal struts and the second row of diagonal struts define a first plurality of cells in the frame, the second row of diagonal struts, the third row of diagonal struts and the plurality of axial frame members define a second plurality of cells in the frame, and the third row of diagonal struts and the fourth row of diagonal struts define a third plurality of cells in the frame.

[0019] 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.

[0020] 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.

[0021] Certain aspects of the present disclosure relate to a prosthetic valve. The prosthetic valve may include an annular frame radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, 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 oblique struts defining the outflow end, a second row of oblique struts located closer to the inflow end than the first row of oblique struts, a plurality of axial frame members bridging the first row of oblique struts and the second row of oblique struts, and a plurality of support members connecting the plurality of axial frame members. The support members may be narrower than the axial frame members, compared to the first row of oblique struts, and compared to the second row of oblique struts. The outer skirt may be connected to the support members.

[0022] According to certain aspects of the present disclosure, the prosthetic valve can include a radially expandable and compressible annular frame and an outer skirt disposed on an outer surface of the annular frame. The annular frame can include a plurality of axial frame members having an inflow end, an outflow end, a first row of oblique struts defining the outflow end, a second row of oblique struts located upstream of the first row of oblique struts, corresponding first and second ends, the first ends being connected to the first row of oblique struts and the second ends being connected to the second row of oblique struts, and a plurality of support members connecting the plurality of axial frame members at connection points located between the first and second ends. The outer skirt can be connected to the support members.

[0023] Certain aspects of the present disclosure also relate to a radially expandable and compressible annular frame. The annular frame may include an inflow end, an outflow end, a row of outflow struts defining the outflow end, a row of inflow struts defining the inflow end, a row of interconnecting struts extending circumferentially between the rows of outflow struts, a plurality of axial frame members each having a corresponding first end and a corresponding second end, the first end being connected to the row of outflow struts and the second end being connected to the row of interconnecting struts, and a plurality of support members connecting the plurality of axial frame members, the plurality of support members extending between the row of outflow struts and the row of interconnecting struts. Each outflow strut may include two angled strut portions interconnected by a top portion. The support members may be narrower in width than the axial frame members, compared to the angled strut portions of the outflow struts, and compared to the row of interconnecting struts.

[0024] According to certain aspects of the present disclosure, a radially expandable and compressible annular frame may include a row of first end struts defining a first end of the annular frame, a row of second end struts defining a second end of the annular frame, a plurality of interconnecting struts arranged in one or more circumferentially extending rows between the first and second row of end struts, a plurality of axial frame members each including a corresponding first end and second end, the first end connected to the row of first end struts and the second end connected to the first row of interconnecting struts, and a plurality of support members connecting the plurality of axial frame members at connection points axially located between the first and second ends.

[0025] Certain aspects of the present disclosure also relate to an assembly. The assembly can include a prosthetic device having a frame, the prosthetic device being transitionable between a radially expanded state and a radially compressed state, and a delivery apparatus configured to deliver the prosthetic device in the radially compressed state to a target location. The frame can include a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, a plurality of axial frame members each including a corresponding first end and a second end, the first end being connected to the row of outflow struts and the second end being connected to the row of interconnecting struts, and a plurality of support members connecting the plurality of axial frame members, the plurality of support members extending between the rows of outflow struts and the rows of interconnecting struts. Each outflow strut can include two angled strut portions interconnected by a crest portion. The support members may be narrower in width compared to the axial frame members, compared to the angled strut portions of the outflow struts, and compared to the rows of interconnecting struts.

[0026] Certain aspects of the present disclosure relate to a method for assembling a prosthetic device. The method may include providing an annular frame including a row of outflow struts defining an outflow end of the annular frame, a row of inflow struts defining an inflow end of the annular frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, and a plurality of axial frame members including corresponding first and second ends, the first end connected to the row of outflow struts and the second end connected to the row of interconnecting struts. The method may also include bridging the plurality of axial frame members with a plurality of support members, the support members extending circumferentially between the rows of outflow struts and the row of interconnecting struts. Each outflow strut may include two angled strut portions interconnected by a crest portion. The support members may be narrower in width compared to the axial frame members, compared to the angled strut portions of the outflow struts, and compared to the rows of interconnecting struts.

[0027] According to certain aspects of the present disclosure, a method for assembling a prosthetic device can include providing an annular frame including a row of outflow struts defining an outflow end of the annular frame, a row of inflow struts defining an inflow end of the annular frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, a plurality of axial frame members including corresponding first and second ends, the first ends being connected to the row of outflow struts and the second ends being connected to the row of interconnecting struts, and a plurality of support members connecting the plurality of axial frame members, the plurality of support members extending between the rows of outflow struts. The method can also include attaching an outflow skirt to an outer surface of the annular frame. The attachment can include connecting an outflow edge portion of the outer skirt to the plurality of support members. Each outflow strut can include two angled strut portions interconnected by a crest portion. The support members may be narrower in width compared to the axial frame members, compared to the angled strut portions of the outflow struts, and compared to the rows of interconnecting struts.

[0028] Certain aspects of the present disclosure also relate to a method including 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 compressible frame. The frame may include a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, a plurality of axial frame members each including a corresponding first end and a second end, the first end being connected to the row of outflow struts and the second end being connected to the row of interconnecting struts, and a plurality of support members connecting the plurality of axial frame members, the plurality of support members extending between the rows of outflow struts and the row of interconnecting struts. Each outflow strut may include two angled strut portions interconnected by a crest portion. The support members may be narrower in width compared to the axial frame members, compared to the angled strut portions of the outflow struts, and compared to the rows of interconnecting struts.

[0029] The above methods can be performed on live animals or can be performed on simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where a body part, tissue, etc. is simulated), etc.

[0030] In certain aspects, the prosthetic valve may include an annular frame transitionable 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 disposed within the frame, the leaflet structure configured to permit blood flow from the inflow end to the outflow end and configured to block blood flow from the outflow end to the inflow end. The frame may include a first row of oblique struts defining the outflow end, a second row of oblique struts positioned upstream from the first row of oblique struts, a third row of oblique struts positioned upstream from the second row of oblique struts, and a plurality of axial frame members each including a corresponding first end and a second end. The first end may be connected to the second row of oblique struts and the second end may be connected to the third row of oblique struts. The plurality of axial frame members may include a plurality of axially extending commissural supports and one or more axial posts positioned between any two immediately adjacent commissural supports. Each commissure support may be configured to support a corresponding commissure of the leaflet structure.

[0031] In certain aspects, the prosthetic valve may include an annular frame transitionable 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 disposed within the frame, the leaflet structure configured to permit blood flow from the inflow end to the outflow end and configured to block blood flow from the outflow end to the inflow end. The frame may include a first row of diagonal struts defining the outflow end, a second row of diagonal struts located upstream of the first row of diagonal struts, a third row of diagonal struts located upstream of the second row of diagonal struts, and a fourth row of diagonal struts located upstream of the third row of diagonal struts, and a plurality of axial frame members including corresponding first and second ends. The first ends may be connected to the second row of diagonal struts and the second ends may be connected to the third row of diagonal struts. The first row of diagonal struts and the second row of diagonal struts may define a plurality of first cells of the frame. The second row of diagonal struts, the third row of diagonal struts and the plurality of axial frame members may define a plurality of second cells of the frame. The third row of diagonal struts and the fourth row of diagonal 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 compared to the number of third cells.

[0032] In certain aspects, an annular frame transitionable between a radially compressed configuration and a radially expanded configuration can include a first row of diagonal struts defining an outflow end, a second row of diagonal struts located upstream of the first row of diagonal struts, a third row of diagonal struts located upstream of the second row of diagonal struts, a fourth row of diagonal struts located upstream of the third row of diagonal struts, and a plurality of axial frame members including corresponding first and second ends. The first ends can be connected to the second row of diagonal struts and the second ends can be connected to the third row of diagonal struts. The first row of diagonal struts and the second row of diagonal struts can define a plurality of first cells of the frame. The second row of diagonal struts, the third row of diagonal struts, and the plurality of axial frame members can define a plurality of second cells of the frame. The third row of diagonal struts and the fourth row of diagonal struts can define a plurality of third cells of the frame. When the frame is in the radially expanded configuration, the first cell can be smaller than the third cell, and the third cell can be smaller than the second cell.

[0033] In certain aspects, the prosthetic valve may include a radially expandable and compressible annular frame that may include a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, an intermediate row of diagonal struts axially positioned between the rows of outflow struts, a plurality of axial frame members bridging the rows of outflow struts and the intermediate row of diagonal struts, and a plurality of support structures connecting the plurality of axial frame members and the intermediate row of diagonal struts. Each support structure may include at least two diagonal support arms connecting two immediately adjacent axial frame members and at least one axial support member bridging the at least two diagonal support arms and the intermediate row of diagonal struts.

[0034] In certain aspects, the prosthetic valve may include a radially expandable and compressible annular frame. The annular frame may include a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, first and second intermediate rows of diagonal struts axially located between the rows of outflow struts and the rows of inflow struts, a plurality of axial frame members bridging the rows of outflow struts and the first intermediate row of diagonal struts, and a plurality of support structures connecting the plurality of axial frame members to the first intermediate row of diagonal struts and the second intermediate row of diagonal struts. The second intermediate row of diagonal struts is upstream from the first intermediate row of diagonal struts. Each support structure may include at least two diagonal support arms connecting two immediately adjacent axial frame members and two or more axial support members bridging the at least two diagonal support arms and the first intermediate row of diagonal struts and the second intermediate row of diagonal struts.

[0035] In some examples, the artificial valve or the frame of the artificial valve can include one or more components described in Examples 1-95 and Examples 107-187 described in the "Additional Examples of the Disclosed Technology" section below.

[0036] The above and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0037] [Figure 1] FIG. 1 is a perspective view of an artificial valve, according to one example. [Diagram 2] FIG. 2 is a perspective view of an artificial valve according to another example. [Diagram 3] FIG. 3 is a perspective view of a prosthetic valve according to yet another example. [Figure 4A]FIG. 4A is a perspective view of an annular frame of a prosthetic valve, according to one example, where the annular frame is in an expanded configuration. [Figure 4B] FIG. 4B is a flattened view of the expanded frame of FIG. 4A. [Figure 4C] FIG. 4C is a flattened view of a portion of the frame of FIG. 4A, where the frame is in a compressed configuration. [Figure 4D] FIG. 4D is a flattened view of a portion of the expanded frame of FIG. 4A, according to an example. [Figure 5A] FIG. 5A is a perspective view of an annular frame of a prosthetic valve according to another example, where the annular frame is in an expanded configuration. [Figure 5B] FIG. 5B is a flattened view of the expanded frame of FIG. 5A. [Figure 5C] FIG. 5C is a flattened view of a portion of the frame of FIG. 5A, where the frame is in a compressed configuration. [Figure 6A] FIG. 6A illustrates an outflow strut of a frame, according to one example, that includes two angled strut portions connected by a U-shaped bend portion. [Figure 6B] FIG. 6B illustrates an inflow strut of a frame, according to one example, formed with two angled strut portions connected by a U-shaped bend portion. [Figure 7A] FIG. 7A illustrates one sequence of frames, according to one example. [Figure 7B] FIG. 7B illustrates one sequence of frames according to another example. [Figure 7C] FIG. 7C illustrates one sequence of frames according to yet another example. [Figure 8A] FIG. 8A illustrates a flattened view of a portion of an annular frame in an expanded configuration, according to another example. [Figure 8B] FIG. 8B illustrates a flattened view of a portion of an annular frame in an expanded configuration, according to another example. [Figure 9A] FIG. 9A illustrates a flattened view of a portion of an annular frame in an expanded configuration, according to another example. [Figure 9B] FIG. 9B illustrates a flattened view of a portion of an annular frame in an expanded configuration, according to another example. [Figure 10] FIG. 10 is a perspective view of a frame of an artificial valve according to another example. [Figure 10A] FIG. 10A is a flattened view of a portion of the frame of FIG. 10, with the frame in an expanded configuration. [Figure 10B] FIG. 10B is a flattened view of a portion of the frame of FIG. 10, with the frame in a compressed configuration. [Figure 11] FIG. 11 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 12] FIG. 12 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 13] FIG. 13 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 14] FIG. 14 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 15] FIG. 15 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 16] FIG. 16 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 17] FIG. 17 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 18] FIG. 18 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 19] FIG. 19 is a flattened view of a portion of a frame for a prosthetic valve, according to another example. [Figure 20]FIG. 20 is 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 OF THE PREFERRED EMBODIMENTS

[0038] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the examples of the disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspects, features, or combinations thereof, nor do the methods, devices, and systems require the presence of any one or more particular advantages or problems to be solved.

[0039] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it will be understood that aspects of the description encompass permutations unless a particular order is required by specific language set forth below. For example, operations described sequentially may in some cases be permuted or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0040] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically couple or connect, and does not exclude the presence of intermediate elements between coupled or associated members, unless specifically stated to the contrary. Additionally, as used herein, "and / or" means "and" or "or," and also means "and" and "or."

[0041] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), while distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in a proximal-distal direction, unless expressly defined otherwise.

[0042] Directions and other relative references (e.g., inside, outside, upper, lower, etc.) may be used herein to facilitate illustration and explanation of the principles, but are not intended to be limiting. For example, certain terms such as "internal," "external," "top," "bottom," "inside," "outside," and the like may be used. Such terms are used where applicable to provide some clarity in dealing with relative relationships, particularly with respect to the illustrated examples. However, such terms are not intended to imply absolute relationships, positions, or orientations. For example, an "upper" part of an object may become a "lower" part simply by flipping it over. It is still the same part, and the object remains the same.

[0043] Overview of artificial valves The prosthetic valves 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 in a radially compressed state and compressed onto or retained by an implant delivery device as it is driven forward through the patient's vasculature on the delivery device. After the prosthetic valve reaches the implantation site, it can be expanded to a radially expanded state. It will be appreciated that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and implanted via a variety of delivery procedures, examples of which will be described in more detail below.

[0044] According to certain examples, any of the prosthetic valves disclosed herein can be adapted for implantation into the native aortic valve annulus. In other examples, any of the prosthetic valves disclosed herein can be adapted for implantation into other native valve annulus of the heart (e.g., pulmonary, mitral, tricuspid). In certain examples, the disclosed prosthetic valves can also be implanted into blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, or blood vessels of the patient. Additionally, the disclosed prosthetic valves can also be implanted inside a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0045] In some examples, the disclosed prosthetic valves can be implanted inside a docking device or anchoring device that is implanted inside a native heart valve or blood vessel. For example, in one example, the disclosed prosthetic valves can be implanted inside a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted inside a docking device implanted inside or at the native mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted inside a docking device implanted inside the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0046] Exemplary Components of a Prosthetic Valve FIG. 1 illustrates an exemplary prosthetic valve 10 that may be driven forward through a patient's vasculature into, such as, a native heart valve by a delivery device, such as the exemplary delivery device shown in FIG.

[0047] As shown, the prosthetic valve 10 includes a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer seal member or outer skirt 18. The frame 12 can be similar to or replaced by any of the frames described herein.

[0048] The frame 12 can have an inflow end 15, an outflow end 19, and an intermediate portion 17 located between the inflow end 15 and the outflow end 19. The valvular structure 14 can be configured to allow unidirectional flow of fluid through the prosthetic valve 10. In certain examples, the valvular structure 14 can include a plurality of leaflets 40 collectively forming a leaflet structure configured to permit blood to flow from the inflow end 15 to the outflow end 19 and to prevent blood from flowing from the outflow end 19 to the inflow end 15.

[0049] For example, the valvular structure 14 can include three leaflets 40, which can be configured to collapse in a tricuspid arrangement. In other examples, a greater or lesser number of leaflets can be provided (e.g., one leaflet, two leaflets, or four or more leaflets). The leaflets 40 can be secured to one another at adjacent sides to form commissures 22 (or "commissural tabs") of the valvular structure 14. The lower (or inflow) edge of the valvular structure 14 can define a curved, scalloped shape, such as an undulating shape, and thus can be referred to as a "scallop line." In some examples, the leaflets 40 can be formed from pericardial tissue (e.g., bovine pericardial tissue), from a biocompatible synthetic material, or from a variety of other suitable natural or synthetic materials, as known in the art and as described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

[0050] Additional examples of leaflet assemblies and methods for attaching the leaflets to a frame are described in U.S. Provisional Patent Application No. 63 / 300,302, filed January 18, 2022, and No. 63 / 278,922, filed November 12, 2021, both of which are incorporated by reference into this specification.

[0051] The frame 12 is radially compressible (crushable) and expandable (e.g., a radially expanded configuration is shown in FIG. 1). The frame 12 can include a plurality of interconnected inclined struts 24. The inflow end 15 and outflow end 19 of the frame 12 can be formed with a plurality of circumferentially spaced apices 26. Although only the apices 26 at the outflow end 19 are shown in FIG. 1, the apices 26 at the inflow end 15 are covered by the outer skirt 18. Each apice 26 can be formed at a junction between two inclined struts 24 at either the inflow end 15 or the outflow end 19. FIG. 1 illustrates an example frame design in which each apice 26 forms a U-shaped bend between two inclined struts 24. In some examples, the angle 30 between two inclined struts 24 connected at an apice 26 can range from 90 degrees to 120 degrees when the frame 12 is in a radially expanded configuration.

[0052] The frame 12 can be formed with a plurality of circumferentially spaced commissure windows 20 adapted to attach the commissures 22 of the valvular structure 14 to the frame 12. For example, the frame 12 can include a plurality of axial frame members 28 spanning two adjacent rows of angled struts 24 located closest to the outflow end 19. The commissure windows 20 can be formed as through-thickness openings (e.g., axially extending slots) 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. Thus, a selected axial frame member 28 having a commissure window 20 can also be referred to as a commissure support.

[0053] The inner skirt 16 (and any inner skirts described herein) and the outer skirt 18 (and any other outer skirts described herein) may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including fabrics (e.g., woven polyethylene terephthalate fabrics) or natural tissues (e.g., pericardial tissue). The inner skirt 16 may be disposed on and / or bonded to the inner surface of the frame 12, while the outer skirt 18 may be disposed on and / or bonded to the outer surface of the frame 12. The outer skirt 18 may function as a seal for the prosthesis 10 by sealing against the tissue of the native annulus, helping to reduce paravalvular leakage through the prosthesis 10. By functioning as a seal, the inner skirt 16 may prevent or reduce paravalvular leakage, anchor the leaflets 40 to the frame 12, and / or protect the leaflets 40 from damage due to contact with the frame 12 during compression and operating cycles of the prosthesis 10. In some instances, the inflow edge of the leaflet 40 may be sutured generally along the scallop line to the inner skirt 16. The inner skirt 16 may be sutured to adjacent angled struts 24 of the frame 12. In other instances, the leaflet 40 may be sutured directly to the frame 12 along the scallop line via stitches.

[0054] 2 illustrates another exemplary prosthetic valve 100 that includes a radially expandable and / or 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 about an outer surface 134 of the frame 102. The frame 102 may be similar to or may be replaced by any of the frames described herein.

[0055] The frame 102 can include a number of angled struts 114 and a number of apices (e.g., outflow apices 108 and inflow apices 138) spaced circumferentially about the outflow end 118 and about the inflow end 116 of the frame 102. Each apice 108 or 138 is formed at a junction between two angled struts 114 at either the outflow end 118 or the inflow end 116.

[0056] Each apex 108 or 138 can have a more rounded or flattened (e.g., less pointed) shape compared to the U-shaped apex 26 in FIG. 1. For example, each apex 108 (or 138) can include a curved or relatively flat outer surface 107 and an arcuate or curved inner recess 109 disposed opposite the outer surface 107 (FIG. 6). The inner recess 109 can form a thinned area at the apex 108 (or 138) having a smaller or narrower width 113 compared to the width 119 of the diagonal strut 114. This thinned area of ​​the apex 108 (or 138) can distribute stresses experienced by the frame 102 away from the apex and through both diagonal struts 114 extending from both sides of the apex 108 (or 138).

[0057] As described herein, the "width" of a frame component (e.g., a diagonal strut or diagonal strut portion, an apex or apex portion, an axial frame member, etc.) is measured between opposite locations on both sides of the frame component that extend between diametrically opposed inner and outer surfaces of the frame component. The width of a frame component can be measured, for example, by flattening the frame onto a plane (see, e.g., Figures 4B and 5B) and measuring the width of a cross-section (i.e., transverse section) of the frame component along a minor axis perpendicular to the longitudinal axis of the frame component and parallel to the plane of the paper.

[0058] The diagonal struts 114 may be arranged in multiple rows between the inflow end 116 and the outflow end 118. For example, FIG. 2 shows four rows of diagonal struts 114: a first row 111 of diagonal struts defining the outflow end 118, a second row 121 of diagonal struts located upstream of the first row 111, a third row 123 of diagonal struts located upstream of the second row 121, and a fourth row 115 of diagonal struts defining the inflow end 116. The first row 111 of diagonal struts may also be referred to as outflow struts, and the fourth row 115 of diagonal struts may also be referred to as inflow struts. In other examples, the frame 102 may include a different number of rows of diagonal struts (e.g., three, five, or more rows). As described herein, a frame component (e.g., a row of inclined struts) is considered to be located upstream of a reference object (e.g., another row of inclined struts) if the frame component is closer to the inflow end 116 (or farther away from the outflow end 118) than the reference object.

[0059] The frame 102 can include a number of axially extending struts, also referred to herein as axial frame members 110, some of which can define commissure windows (similar to those designated by numeral 20) therein. The lateral portions of adjacent leaflets 104 can be paired and can extend through the commissure windows, thereby forming commissures 112 that are fixed relative to the frame 102.

[0060] The axial frame member 110 may bridge the diagonal struts of the first row 111 and the diagonal struts of the second row 121. For example, an upper end 146 of the axial frame member 110 may be connected to a lower end of the diagonal strut of the first row 111, and a lower end 148 of the axial frame member 110 may be connected to an upper end of the diagonal strut of the second row 121.

[0061] The axial frame member 110, together with the first row 111 of angled struts and the second row 121 of angled struts, may form a circumferentially extending row of open outflow cells 126 (which may also be referred to as the "first cells" or "upper cells"). The first row 111 of angled struts may form upper or outflow edges of the outflow cells, and the second row 121 of angled struts may form lower or inflow edges of the outflow cells 126. The rows of angled struts located upstream of the first row 111 (e.g., rows 121, 123, 115) may be interconnected to form additional rows of open cells. For example, FIG. 2 shows a second row of middle cells 125 located proximate to the middle portion 117 of the frame 102 and a third row of inflow cells 127 located at the inflow end 116 of the frame 102. The outflow cells 126 can have a hexagonal shape when the frame 102 is radially expanded. In certain examples, the outflow cells 126 can be axially longer and have a larger open area compared to the middle cells 125 and the inflow cells 127.

[0062] 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 angled struts of the fourth row 115) via one or more fasteners, such as whip 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 angled struts of the second row 121 that form the lower or inflow edge of the outflow cell 126. In some examples, the lower end 148 of the axial frame member 110 can include an opening 132 through which the sutures 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.

[0063] 2, the outflow edge portion 122 of the outer skirt 106 may conform to and follow the shape of the inclined struts 114 that form the lower or inflow edges of the outflow cells 126, thereby affixing the outflow edge portion 122 to follow the zigzag pattern of the inclined struts of the second row 121 (e.g., via stitching 130). Although such a configuration may result in a tight attachment of the outflow edge portion 122 of the outer skirt 106 to the frame 102, it also results in the outer skirt 106 having a relatively short axial height 128, as illustrated in FIG. 2, measured along a portion of the outer skirt 106 that extends axially from a non-top junction near the inflow end 116 (e.g., the junction where the inclined struts of the third row 123 and the fourth row 115 are connected) to the bottom junction of the outflow cells 126.

[0064] In certain circumstances, it may be desirable for the outer skirt to extend beyond the lower or inflow edges of the outflow cells 126, for example, above the angled struts of the second row 121 (i.e., closer to the outflow end 118). For example, it may be desirable for the outflow edge portion 122 of the outer skirt 106 to extend toward the outflow end 118 (e.g., closer to the mid-height of the outflow cells 126) to provide an increased surface area for improved sealing to reduce paravalvular leakage at the implantation site.

[0065] 3 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 may be similar to or may be replaced by any of the frames described herein. The prosthetic valve 150 may include leaflets 104 assembled to the frame 102 as shown in FIG. 2 and described above.

[0066] 3, the outer skirt 156 can extend around the exterior of the frame 102 from the inflow end 116 (covered by the outer skirt 156) to the outflow end 118 of the frame 102. In some examples, the outer skirt 156 can be secured to the struts of the frame 102 at the inflow end 116 by one or more sutures 164.

[0067] 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 angled struts of the second row 121 by one or more sutures 166. In some examples, a portion of the sutures 166 can extend through and be secured to the openings 132 in the lower end 148 of the axial frame member 110 (the openings 132 are shown in dashed lines in FIG. 3 to indicate their location below the outer skirt 156).

[0068] In some examples, the sutures 166 and / or the sutures 164 can be in-and-out stitches. In some examples, the sutures 166 can be continuous between adjacent openings 132 (e.g., extending in and out of the outer skirt 156). In other examples, the sutures 166 can be individual members that individually connect the outflow edge portions 152 of the outer skirt 156 to their respective axial frame members 110.

[0069] In some examples, as shown in FIG. 3, additional sutures 168, which may be configured as whip stitches, may further secure the outer skirt 156 to angled struts of the frame 102, which may be disposed 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).

[0070] Unlike the prosthetic valve 100 of Figure 2, in which the outflow edge portion 122 of the outer skirt 106 follows the zigzag pattern of the angled struts of the second row 121, the prosthetic valve 150 of Figure 3 may have a larger outer skirt 156 such that the outflow edge portion 152 may have approximately the same height around the circumference of the frame 102 (i.e., may have a substantially constant axial distance relative to the inflow end 116). Thus, the outer skirt 156 may cover at least a lower portion of the outflow cells 126.

[0071] To provide additional structural support for the outer skirt 156, for example to reduce the likelihood that the outflow edge portion 152 of the outer skirt 156 will extend through or hang loosely across the outflow cells 126 (e.g., due to the relatively large size of the outflow cells 126), runs of support members extending between the axial frame members 110 may be added to the frame 102 to further attach the outflow edge portion 152 of the outer skirt 156 to the support members. Examples of frames with runs of support members are described further below.

[0072] Further details regarding the prosthetic valve and its various components, including associated delivery devices / catheters / systems, are described in WIPO Patent Application Publication No. WO2018 / 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 August 26, 2022, which is also incorporated herein by reference.

[0073] Exemplary Frame with Stages of Support Members 4A-4D illustrate a frame 200 that may be incorporated into any of the prosthetic valves described herein (e.g., 10, 100, 150). Similarly, the frame 200 is capable of transitioning between a radially compressed configuration and a radially expanded configuration.

[0074] As shown in FIG. 4A, the frame 200 has an inflow end 216 (also referred to as the "second end" or "inflow end"), an outflow end 218 (also referred to as the "first end" or "outflow end"), and a number of inclined struts 202 arranged in a number of circumferentially extending rows between the inflow end 216 and the outflow end 218.

[0075] 4B, the frame 200 has four rows of oblique struts 202: a first row 222 of oblique struts defining the outflow end 218, a second row 224 of oblique struts upstream from the first row 222, a third row 226 of oblique struts upstream from the second row 224, and a fourth row 228 of oblique struts upstream from the third row 226 and defining the inflow end 216. The oblique struts in the first row 222 may also be referred to as "outflow struts" 208 or "first end struts," and the oblique struts in the fourth row 228 may also be referred to as "inflow struts" 209 or "second end struts." Although four rows of inclined struts are illustrated in Figures 4A-4D, it will be understood that in other examples, the frame 200 can have fewer (e.g., three) or more (e.g., five, six, seven, etc.) rows of inclined struts 202 between the inflow end 116 and the outflow end 218.

[0076] In the illustrated 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 be curved between the pair of angled strut portions 204 of the corresponding outflow strut 208. In certain examples, each apex portion 205 can have an arc length that extends along at least 25% of the full 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., FIGS. 4B and 4D). In certain examples, each apex portion 207 can have an arc length that extends along at least 25% of the full arc length of the corresponding inflow strut 209. 2, the apex portions 205,207 may be thinner or narrower (eg, have a smaller width) as compared to the corresponding angled strut portions 204,206.

[0077] Similar to the apices 108, 138 in Figure 2, the apices 205, 207 are more rounded and more flattened. In another example, as shown in Figure 6A, the apices 205 can form a U-shaped bend (similar to the apices 26 in Figure 1) between the two angled strut portions 204 of the corresponding outflow strut 208. Similarly, as shown in Figure 6B, the apices 207 can form a U-shaped bend between the two angled strut portions 206 of the corresponding inflow strut 209.

[0078] 4A-4D, the frame 200 also includes a plurality of axially extending posts, or axial frame members 210, that span two rows (e.g., first row 222 and second row 224) of inclined struts 202 located proximate the outflow end 218. The axial direction of the frame 200 is represented by a longitudinal axis 201 that extends from the inflow end 216 to the outflow end 218.

[0079] Each axial frame member 210 can have a first end 212 connected to the diagonal struts of the first row 222 and a second end 214 connected to the diagonal struts of the second row 224. For example, as shown in FIG. 4B, the diagonal struts of the first row 222 can be joined to form a first set of alternating upper ends (or peaks) 222U and lower ends (or valleys) 222L at the outflow peak portion 205 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 located closer to the inflow end 216 than the upper ends 222U. The diagonal struts of the second row 224 can be joined to form a second set of alternating upper ends (or peaks) 224U and lower ends (or valleys) 224L. The upper ends 224U are located closer to the outflow end 218 than the lower ends 224L. As shown, the axial frame member 210 can connect the lower ends 222L of the diagonal struts of the first row 222 to the upper ends 224U of the diagonal struts of the second row 224, respectively.

[0080] According to a particular example, selected axial frame members 210 can be configured as commissure supports 232, each of which can support a corresponding commissure of a valvular structure (e.g., including leaflets similar to 40 or 104 as described above) mounted within the frame 200. In the illustrated example, the frame 200 includes three axially extending commissure supports 232 configured to receive 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 shaped and sized to receive a commissure of two adjacent leaflets therethrough. In other examples, the commissure window 236 can have any of a variety of shapes (e.g., square, elliptical, square-elliptical, triangular, L-shaped, T-shaped, C-shaped, etc.).

[0081] The commissural supports 232 (and thus the commissural windows 236) may be angularly spaced apart from one another around the circumference of the frame 200. The commissural supports 232 may or may not be evenly spaced apart.

[0082] 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. As an example, the axial location of the commissure window 236 can be selected such that when each leaflet is attached to the frame 200 via the commissure window 236, a free edge portion (e.g., an outflow edge portion) of each leaflet does not protrude beyond or extend beyond the outflow end 218 of the frame 200.

[0083] Other axial frame members 210 (i.e., not commissural supports 232), which may also be referred to as axial posts 234, are disposed between every two immediately adjacent commissural supports 232. For example, the frame 200 may have two axial posts 234 located between each pair of immediately adjacent commissural supports 232.

[0084] Although the frame 200 illustrated in Figures 4A-4B has a total of nine axial frame members 210 (including three commissure supports 232 and six axial posts 234), it will be understood that the frame 200 may have more or fewer than nine axial frame members 210 (e.g., more or fewer than three commissure supports 232 and / or a different number of axial posts 234).

[0085] The multiple rows of diagonal struts 202 and the axial frame members 210 can form multiple rows of open cells in the frame 200. For example, the first row 222 of diagonal struts, the second row 224 of diagonal struts, and the multiple axial frame members 210 can define a multiple first cells 230 (also referred to as "outflow cells") in the frame 200. The first cells 230 can have a hexagonal shape when the frame 200 is in the expanded configuration.

[0086] In a particular example, the diagonal struts of the second row 224 and the diagonal struts of the third row 226 can define a plurality of second cells 238 in the frame 200. Similarly, the diagonal struts of the third row 226 and the diagonal struts of the fourth row 228 can define a plurality of third cells 240 (also referred to as "inflow cells") in the frame 200. Each of the second cells 238 and the third cells 240 can have a quadrilateral shape when the frame 200 is in the expanded configuration.

[0087] In general, the first cell 230 can have a larger axial length (and larger area) compared to the second cell 238 and compared to the third cell 240, resulting in more open space, or a larger opening, for blood flow and coronary access near the outflow end 218.

[0088] As described herein, the multiple columns of open cells 230, 238, 240 may be arranged as multiple rows of the frame 200 defined by the axial frame members 210. For example, the frame 200 illustrated in Figure 4B has nine rows defined by nine axial frame members 210, where each row is formed by one first cell 230, one third cell 240 adjacent to the first cell 230, and two partial second cells 238 located between the first cell 230 and the third cell 240.

[0089] In certain examples, the second cells 238 and the third cells 240 have approximately the same size when the frame 200 is in the expanded configuration. In other examples, 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 approximate a diamond shape (e.g., the diagonal struts in the second row 224 and the diagonal struts in the third row 226 that define each second cell 238 can have equal lengths), and the third cells 240 can have a shape that is not diamond shaped, such as where the angle formed at each apex portion 207 (i.e., the angle between a pair of diagonal strut portions 206) is greater compared to the opposing angle formed between a pair of diagonal struts in the third row 226.

[0090] As shown in FIGS. 4A-4D, the frame 200 can further include a row of support members 250 that connect the axial frame members 210 and extend between the diagonal struts of the first row 222 and the diagonal struts of the second row 224. Some of the support members 250 can connect between pairs of immediately adjacent axial posts 234. Some of the support members 250 can connect the commissure supports 232 to immediately adjacent axial posts 234. As described herein, the support members 250 can be used for attachment of an outer skirt (similar to 18, 106, 156) that is attached on the outer surface of the frame 200. For example, the outflow edge portion (e.g., 122, 152) of the outer skirt can be connected to the support members 250 via sutures.

[0091] The support members 250 can be configured to be axially foldable. For example, each support member 250 can include two arm portions 252 (hereinafter also referred to as "angled support arms") and a joint portion 254 (e.g., in the form of an angled strut) connecting the two arm portions 252, at which the support members 250 can be folded when the frame 200 transitions from a radially expanded configuration (see, e.g., FIG. 4A) to a radially compressed configuration (see, e.g., FIG. 4C). When folded, the two arm portions 252 of each support member 250 can be configured to extend between and substantially parallel to two immediately adjacent axial frame members 210.

[0092] 4A-4B, the interface 254 of each support member 250 forms a U-shaped curved portion between the corresponding pair of arm portions 252 and extends upward (i.e., toward the outflow end 218). In another example, shown in FIG. 4D, the interface 254 of each support member 250 can be curved (similar to the more rounded or flatter top portions 205, 207) between the corresponding pair of arm portions 252. In some examples, the two arm portions 252 can form an obtuse angle (e.g., >90 degrees) at the interface 254 when the frame 200 is radially expanded.

[0093] Each support member 250 can connect two immediately 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. In the example illustrated in Figures 4A-4D, each arm portion 252 is substantially straight except for an end portion 256 opposite the joint portion 254, which can be curved. The end portion 256 is where the support member 250 is connected to the corresponding axial frame member 210. Thus, the end portion 256 can also be referred to as an attachment portion.

[0094] The support member 250 can be configured to have a smaller width compared to any other strut component of the frame 200. For example, the support member 250 can be narrower in width compared to the axial frame members 210 (including the commissure supports 232) in any row (e.g., 222, 224, 226, 228) and compared to the diagonal struts 202. As described herein, when the outflow strut 208 or inflow strut 209 has a thinned top portion (e.g., 205, 207), the width of the outflow strut 208 or inflow strut 209 refers to the width of the corresponding diagonal strut portion 204, 206. Thus, as described herein, the support member 250 is narrower in width compared to the diagonal strut portion 204 of the outflow strut 208 and compared to the diagonal strut portion 206 of the inflow strut 209.

[0095] In certain instances, the angled struts 202 in any row (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 systole, thereby distributing stress and reducing the extent to which the leaflets may fold radially outward through the first cell 230 and onto the axial frame member 210. As a result, the long term durability of the leaflets may be increased.

[0096] Increasing the width of the axial frame member 210 can reduce the area of ​​the first cell 230, especially when the frame 200 is radially compressed. As described herein, the support member 250 is configured to be thin enough, i.e., narrow enough, that the folded support member 250 can fit inside the narrowed (elongated) first cell 230 when the frame 200 is radially compressed (see, e.g., FIG. 4C). This can be accomplished, for example, by forming the support member 250 from a fully annealed metal, such as cobalt chrome, stainless steel, or the like.

[0097] In certain examples, the diagonal struts in the first row 222 (i.e., the outflow struts 208) and the diagonal struts in the fourth row 228 (i.e., the inflow struts 209) can have approximately the same width. The diagonal struts in the second row 224 and the diagonal struts in the third row 226 can have approximately the same width.

[0098] In a particular example, the inclined struts in the second row 224 and the inclined struts in the third row 226 are narrower in width than the inclined struts in the first row 222 (i.e., the outflow struts 208) and than the inclined struts in the fourth row 228 (i.e., the inflow struts 209).

[0099] In particular examples, the width of support member 250 can range from 0.1 mm to 0.3 mm, or from 0.18 mm to 0.22 mm, inclusive. In one embodiment, the width of support member 250 is approximately 0.20 mm.

[0100] In particular examples, the width of the angled strut portion 204 of the outflow strut 208 and the width of the angled strut portion 206 of the inflow strut 209 can range from 0.3 mm to 0.5 mm, or from 0.38 mm to 0.42 mm, inclusive. In one embodiment, the width of the angled strut portions 204, 206 is approximately 0.4 mm.

[0101] In particular examples, the width of the apex portion 205 of the outflow strut 208 and the width of the apex portion 207 of the inflow strut 209 can range from 0.15 mm to 0.25 mm, or from 0.18 mm to 0.22 mm, inclusive. In one embodiment, the width of the apex portions 205, 207 is approximately 0.20 mm.

[0102] In particular examples, the width of any of the angled struts 202 (e.g., angled struts in the second row 224 and angled struts in the third row 226) other than the outflow struts 208 and other than the inflow struts 209 can range from 0.15 mm to 0.35 mm, or from 0.23 mm to 0.27 mm, inclusive. In one embodiment, the width of any of the angled struts 202 in the second row 224 and in the third row 226 is approximately 0.25 mm.

[0103] In certain examples, the width of the axial frame member 210 can range from 0.2 mm to 2 mm, or from 0.8 mm to 1.2 mm, inclusive. In certain examples, the commissure support 232 (i.e., the axial frame member having the commissure window 236) is wider than the axial post 234. In any of the examples described herein, where the commissure support 232 has a variable width along its axial length (e.g., the portion of the commissure support 232 surrounding the commissure window 236 can be wider than the portion of the commissure support located above and below the commissure window), the width of the commissure support 232 refers to the maximum width along the entire axial length of the commissure support 232. In some examples, the axial post 234 can have a width in the range of 0.3 mm to 1.5 mm, or from 0.6 mm to 1 mm, inclusive. In a particular example, 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 examples, each commissural support 232 can have a non-uniform width between the first end 212 and the second end 214 of the commissural support 232. For example, each commissural support 232 can have a middle portion 231 defining a commissural window 236 and two end portions 233 located above and below the commissural window 236, where the middle portion 231 can be wider than the two end portions 231. In a particular example, the middle portion 231 of the commissural support 232 can have a width ranging from 1.2 mm to 1.6 mm, inclusive (e.g., 1.4 mm). The end portions 233 located above and below the commissural window 236 can have a width ranging from 1.0 mm to 1.4 mm, inclusive (e.g., 1.2 mm). In a particular example, the commissure window 236 can have a width ranging from 0.5 mm to 0.7 mm, inclusive (eg, 0.6 mm).

[0104] As described herein, each support member 250 may be connected to two immediately adjacent axial frame members 210 at a corresponding connection point 258, which may be at the first end 212, the second end 214, or any location between the first end 212 and the second end 214 of the axial frame member 210.

[0105] In the example shown in Figures 4A-4D, 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 cell 230 into corresponding upper and lower cell portions 230U and 230L, where the upper cell portion 230U is located closer to the outlet end 218 than the lower cell portion 230L. In the illustrated example, the upper cell portion 230U is larger than the lower cell portion 230L when the frame 200 is in the radially expanded configuration. In other examples, the lower cell portion 230L can be larger than the upper cell portion 230U or can have approximately the same size when the frame 200 is in the radially expanded configuration. In the illustrated example, the lower cell portion 230L has a quadrilateral shape when the frame 200 is in the radially expanded configuration. When an outer skirt (similar to 18, 106, 156) is attached to the support member 250, the lower cell portion 230L can be covered by the outer skirt, while the upper cell portion 230U can provide an opening for coronary artery access.

[0106] In the example shown in Figures 4A-4D, the joint portion 254 of each support member 250 is configured to move axially toward the outflow end 218 (and thus away from the inflow end 216) when the frame 200 is radially compressed (and thus when the corresponding arm portion 252 is allowed to fold), and is configured to move axially toward the inflow end 216 (and thus away from the outflow end 218) when the frame 200 is radially expanded (and thus when the corresponding arm portion 252 is allowed to unfold).

[0107] 5A-5C illustrate another radially expandable and compressible frame 260 that may be incorporated into any of the prosthetic valves described herein (e.g., 10, 100, 150). Similar to 200, frame 260 includes four rows (e.g., 222, 224, 226, 228) of oblique struts 202 and a plurality of axial frame members 210 including three commissural supports 232 with corresponding commissural windows 236 and six axial posts 234 circumferentially distributed between the commissural supports 232. Similarly, the rows of oblique struts 202 and the rows of axial frame members 210 may define a row of first cells 230, a row of second cells 238, and a row of third cells 240.

[0108] 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, with each arm portion 252 connected to a corresponding axial frame member 210 at a corresponding connection point 258. In the example illustrated in Figures 5A-5C, each arm portion 252 is configured to be substantially straight. Similarly, the support members 250 can be configured to be narrower in width than the axial frame members 210 and than the diagonal struts 202 in any row (e.g., 222, 224, 226, 228).

[0109] 4A-4D, where the connection point 258 overlaps the second end 214 of the axial frame member 210, in the example shown in Figures 5A-5C the connection point 258 is axially located between the first end 212 and the second end 214 of the axial frame member. Thus, only the second row 224 of oblique struts are connected to the second end 214 of the axial frame member 210.

[0110] 5A-5C, for a support member 250 connected to a commissure support 232, a corresponding connection point 258 can be located between the first end 212 and the commissure window 236, i.e., the connection point 258 can be axially spaced apart from the commissure window 236. In other examples, the connection point 258 can be axially spaced apart along the commissure window 236. The commissure support 232 has less material, or less mass, along the portion of the support 232 that forms the window. Thus, in certain examples, locating the connection point 258 away from the commissure window 236 can improve stability of the connection point 258 (e.g., reducing the likelihood that the connection point will bend inward and compress the commissure tabs when the frame 260 is expanded).

[0111] In some examples, as illustrated in FIGS. 5A-5C, the axial posts 234 can include openings 235 (similar to 132 in FIG. 3) configured to allow a suture to extend therethrough to secure the outer skirt to the axial post 234. In the illustrated example, the openings 235 are located near the second end 214 of the axial post 234. In other examples, the openings 235 can be located at a location between the first end 212 and the second end 214 of the axial post 234. In yet another example, the openings 235 can be located near the first end 212 of the axial post 234. In the illustrated example, each axial post 234 has one opening 235. In other examples, some axial posts 234 can have two or more openings 235 or can have no openings 235. In yet other examples, some of the commissure supports 232 can also have multiple openings 235 , which can be located above and / or below the commissure window 236 .

[0112] Similarly, the support member 250 can divide the first cell 230 into corresponding upper and lower cell portions 230U and 230L. In the example shown in FIG. 5B, the upper cell portion 230U is smaller than the lower cell portion 230L when the frame 260 is in the radially expanded configuration. In other examples, the upper cell portion 230U can be larger than or have approximately the same size as the lower cell portion 230L when the frame 260 is in the radially expanded configuration. In the illustrated example, the upper cell portion 230U has a hexagonal shape and the lower cell portion 230L has an irregular hexagonal shape when the frame 260 is in the radially expanded configuration.

[0113] In the example illustrated in Figures 5A-5C, 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 (and thus away from the outflow end 218) when the frame 260 is radially compressed (and thus the corresponding arm portion 252 is allowed to fold), and is further configured to move axially toward the outflow end 218 (and thus away from the inflow end 216) when the frame 260 is radially expanded (and thus the corresponding arm portion 252 is allowed to unfold). As shown in Figure 5C, when folded, the two arm portions 252 of each support member 250 can be configured to extend between and substantially parallel to two immediately adjacent axial frame members 210.

[0114] The connection point 258 may be configured to be located at other locations on the axial frame member 210 .

[0115] 7A shows one row of the frame 270, where the support members 250 are connected to the commissure supports 232 and to the axial posts 234. The connection points 258 on the commissure supports 232 are located between the second ends 214 and the commissure windows 236. The connection points 258 on the axial posts 234 are located above and adjacent to the second ends 214, and have openings 235. The interface portions 254 between the support members 250 extend upward (sharpened toward the outflow ends 218). Thus, when the frame 270 is radially compressed, the interface portions 254 can move toward the outflow ends 218 (away from the inflow ends 216) as the two arm portions 252 fold between the commissure supports 232 and the axial posts 234.

[0116] As another example, FIG. 7B shows a row of another frame 280 where the support members 250 are connected to the commissure supports 232 and to the axial posts 234. In this example, the connection points 258 on both the commissure supports 232 and the axial posts 234 are located approximately midway between the corresponding first and second ends 212 and 214. In FIG. 7B, the commissure windows 236 can be configured to be smaller than those shown in FIG. 7A. In the illustrated 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 illustrated example, the interface portions 254 of the support members 250 extend upward and can move toward the outflow end 218 when the frame 280 is radially compressed. In other examples, the interface portion 254 can extend downward and move toward the inflow end 216 when the frame 280 is radially compressed.

[0117] As yet another example, Figure 7C illustrates a row of another frame 290 in which support members 250 are connected to commissure supports 232 and to axial posts 234. In this example, connection points 258 on both the commissure supports 232 and the axial posts 234 are located near their respective first ends 212. Interface portions 254 of support members 250 extend toward the inflow end 216 and can move toward the inflow end 216 when the frame 290 is radially compressed.

[0118] In certain examples, as illustrated in Figures 7A-7C, the attachment or end portion 256 of each arm portion 252 can have a curved shape, and each arm portion 252 can be connected to a corresponding commissure support 232 or to a corresponding axial post 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 interface portion 254 of the support member 250 extends upward (see, e.g., Figures 7A-7B), the corresponding attachment portion 256 can form an arc of a circle whose center is located below the connection point 258, i.e., upstream from the connection point 258. Conversely, when the interface portion 254 extends downward (see, for example, FIG. 7C ), the corresponding attachment portion 256 can form an arc of a circle whose center is located above the connection point 258, i.e., the arc of a circle whose center is located downstream from the connection point 258.

[0119] It will be understood that the illustrated examples in FIGS. 7A-7C 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 from or aligned with an opening (e.g., commissure window 236 and / or opening 235) on the axial frame member 210. In various examples, the interface portion 254 of the support member 250 can extend toward the inflow end 216 or the outflow end 218. Additionally, the angle formed at the interface portion 254 between the corresponding pair of arm portions 252 when the frame is in the radially expanded configuration can also vary, for example, from 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.

[0120] Such design variations may allow the connection points 258 and / or interfaces 254 to be located at different heights relative to the axial frame member 210. Thus, an outer skirt that may be attached to the support member 250 may cover different regions of the first cell 230.

[0121] In certain examples, the interface 254 can be located closer to the outflow end 218 compared to the second end 214 of the axial frame member 210 when the frame is in the radially expanded configuration. In certain examples, the interface 254 can be axially aligned to a midpoint between the first end 212 and the second end 214 when the frame is in the radially expanded configuration.

[0122] In certain examples, the connection point 258 can be axially closer to the first end 212 as compared to a midpoint between the first end 212 and the second end 214. In certain examples, the midpoint between the first end 212 and the second end 214 can be axially closer to the first end 212 as compared to the connection point 258.

[0123] In certain examples, the interface 254 of the support member 250 can be axially closer to the second end 214 compared to the connection point 258 when the frame is in the radially expanded configuration. In certain examples, the interface 254 of the support member 250 can be axially closer to the first end 212 compared to the connection point 258 when the frame is in the radially expanded configuration. In one embodiment, the interface 254 can be axially aligned with the first end 212 of the axial frame member 210 when the frame is in the radially expanded configuration.

[0124] In some examples, the axial distance H (see, e.g., FIGS. 4B and 5B ) between the inflow end 216 of the frame and the interface portion 254 of the support member 250 when the frame is in the radially expanded configuration can be at least 10 mm. In some examples, the axial distance H can be from one-third to two-thirds of the frame height (i.e., the axial distance measured between the inflow end 216 and the outflow end 218) when the frame is in the radially expanded configuration.

[0125] 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 of the first cell 230 (e.g., lower cell portion 230L). By extending across a middle portion of the first cell 230, the support member 250 can provide additional structural support to the outer skirt. In some instances, such additional structural support to the outer skirt can reinforce the connection of the outflow edge of the skirt to the frame and help reduce the likelihood that a portion of the outflow edge portion of the outer skirt will protrude inwardly through the first cell 230 and contact the leaflet 104.

[0126] In some examples, the outflow edge portion of the outer skirt can be axially disposed 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 located closer to the outflow end 218 of the frame as compared to the second end 214 of the axial frame member 210. In one embodiment, the outflow edge portion of the outer skirt can be axially aligned with a midpoint between the first end 212 and the second end 214 of the axial frame member 210. In another embodiment, the outflow edge portion of the outer skirt can be axially aligned with the first end 212 of the axial frame member 210.

[0127] To assemble the prosthetic valve, an annular frame having stages of support members as described above can be prepared. In certain examples, 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 to one another. In other examples, the frame can be constructed from a single piece of material (e.g., Nitinol, stainless steel, cobalt chromium alloy, etc.), such as in the form of a tube. A plurality of cells, 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.).

[0128] In certain examples, a frame may be constructed first to include rows of diagonal struts and axial frame members, and then support members may be added (e.g., welded) and connected to the axial frame members.

[0129] After the frame is formed, a valvular structure including multiple leaflets (similar to 40 or 104) can be attached within the frame. In certain instances, an inner skirt (similar to 16) can be attached to an inner surface of the frame, the inner skirt configured to be positioned between the leaflets and the inner surface of the frame. An outer skirt (similar to 18, 106, 156) can be attached onto an outer surface of the frame. An inflow edge portion of the outer skirt can be secured to the inflow struts of the frame, and an outflow edge portion of the outer skirt can be connected to the support members, e.g., via stitching. In certain instances, the outflow edge portion of the outer skirt can also be connected to at least some of the axial frame members, e.g., via stitching.

[0130] Exemplary Frame with Reinforced Outflow End Portion In some circumstances, after receiving a transcatheter aortic valve replacement procedure, a patient may need to undergo a post-implantation procedure that requires open-heart surgery using a heart-lung machine. During open-heart surgery, an aortic cross-clamp is often used to clamp the aorta and isolate the systemic circulation from the outflow from the heart. If the aortic cross-clamp is placed in a position corresponding to the implanted prosthetic valve, the aortic cross-clamp may deform the prosthetic valve, especially if the prosthetic valve has a plastically deformable frame.

[0131] As described herein, any of the prosthetic valves described herein (e.g., 10, 100, 150) can be reinforced to have improved crush resistance to the compressive forces applied by an aortic cross clamp. This can be accomplished, for example, by reinforcing the outflow end portion of the frame downstream from the valve leaflets. It is desirable to limit the reinforcement to the outflow end portion of the frame, since further reinforcement of other portions of the frame would require the balloon to be inflated in a manner that would apply greater force to expand the frame, which could damage or even tear the valve leaflets. Such risk can be reduced if the reinforced frame portion is located downstream from the valve leaflets.

[0132] In some examples, the prosthetic valve can be reinforced by reinforcing the outflow struts of the frame, such as by thickening and / or widening the outflow struts. As an example, the struts 111 in the first row of the frame 102 can have a greater width compared to the struts in the other rows (121, 123, 115). As another example, the struts 222 in the first row of the frame 200 can have a greater width compared to the struts in the other rows (224, 226, 228). In certain circumstances, 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 reinforced by using metal and / or alloy materials that are stronger compared to the rest of the frame.

[0133] In some examples, the outflow end portion of the frame can be reinforced by adding a step of support members, similar to the examples shown in Figures 5A-5B and 7C. For example, a step of support members 250 can be added between the axial frame members 210 with the connection points 258 adjacent to the outflow struts 208 (as in the example of Figures 5A-5B) or with the connection points 258 overlapping the first ends 212 of the axial frame members 210 (as in the example of Figure 7C). Thus, instead of or in addition to functioning as support arms for attachment of the outer skirt, the step of support members 250 shown in Figures 5A-5B and 7C can also reinforce the strength of the outflow end portion of the frame. In some examples, the outflow end portion of the frame can be reinforced by incorporating a step of support members, similar to the examples shown in Figures 5A-5B and 7C, and / or by thickening and / or widening the outflow struts 208 as described above.

[0134] In some examples, the outflow end portion of the frame can be reinforced by adding one or more optional axial support struts bridging the step of the support member and the outflow strut. For example, FIG. 4D illustrates an axial support strut 225 (shown in dashed lines to indicate that it is optional) connecting between the junction portion 254 of the support member 250 and the top portion 205 of the outflow strut 208. In such a case, the axial support strut 225 can further divide the upper cell portion 230U of the first cell 230 into two side-by-side half portions. In some examples, an axial support strut 225 can bridge each pair of support members 250 and outflow struts 208 (i.e., each cell portion 230U of the frame includes an axial support strut 225). In other examples, the axial support strut 225 may bridge selected pairs of support members 250 and outflow struts 208 (e.g., every other cell portion 230U may include an axial support strut 225).

[0135] 5A-5B and 7C, the connection points 258 for the stages of support members 250 are positioned on the axial frame member 210 such that the stages of support members 250 are upstream from the outflow struts 208 and divide the outflow cells 230 into upper and lower cell portions 230U and 230L. In other examples, the outflow end portion of the frame can be reinforced by adding stages of support members downstream from the outflow struts, as described below.

[0136] 8A-8B and 9A-9B illustrate additional example frames 200a, 200b, 200c, and 200d, each of which may be incorporated into any of the prosthetic valves described herein (e.g., 10, 100, 150). Similarly, each frame 200a, 200b, 200c, or 200d may transition between a radially compressed configuration and a radially expanded configuration.

[0137] Frame 200a shown in FIG. 8A is similar to frames 200, 260, 270, 280, and 290 described above, except for the arrangement of the stages of support members. As shown, frame 200a has a stage of support members 251 connected to and downstream of outflow struts 208. As a result, outflow end 218' of frame 200a is defined by the stage of support members 251 instead of outflow struts 208. Specifically, outflow struts 208 are joined at alternating upper and lower ends 208U and 208L. Upper end 208U is axially between lower end 208L and outflow end 218'. In other words, lower end 208L is upstream of upper end 208U, and upper end 208U is upstream of outflow end 218'. Each of the axial frame members 210 (including the commissure supports 232 and the axial posts 234) is connected to one of the lower ends 208L in this example.

[0138] Frame 200b, shown in FIG. 8B, is identical to 200a, except that axial frame member 210 (including commissure supports 232 and axial posts 234) is connected to upper end 208L.

[0139] When a row of support members 251 is located downstream of the outflow struts 208, the row of support members 251 can also be considered a row of diagonal struts. Thus, frame 200a or 200b has at least five rows of diagonal struts: a first row 221 of diagonal struts defined by the row of support members 251, a second row 222 of diagonal struts defined by the outflow struts 222, a third row 224 of diagonal struts located upstream of the second row 222, a fourth row 226 of diagonal struts located upstream of the third row 224, and a fifth row 228 of diagonal struts located upstream of the fourth row 226. Rows 222, 224, 226, and 228 each correspond to the rows of the same reference numbers in FIG. 4B. In the illustrated example, axial frame member 210 (including commissure supports 232 and axial posts 234) connects the second row 222 and the third row 224, with the fifth row 228 defining the inflow end 216. In other examples, frame 200a or 200b can have more than six rows of angled struts (e.g., additional rows of angled struts can be added upstream of the fifth row 228).

[0140] Similarly, the additional tier of support members 251 can increase the strength of the outflow end portion of the frame 200a or 200b. In some examples, the outflow end portion of the frame 200a or 200b can be further reinforced by thickening and / or widening the outflow struts 208 as described above. For example, the diagonal struts in the second row 222 (outflow struts 208) can be wider compared to the diagonal struts in the other rows (221, 224, 226, 228). In some examples, the diagonal struts in the first row 221 (tier of support members 251) can have a smaller width compared to the diagonal struts in the other rows (222, 224, 226, 228). In some examples, the diagonal struts in the first row 221 can have the same width compared to the diagonal struts in the second row 222, the diagonal struts in the third row 224, the diagonal struts in the fourth row 226, and / or the diagonal struts in the fifth row 228.

[0141] 8A-8B, frame 200a or 200b may have at least four rows of open cells, i.e., the first row 221 and the second row 222 may together define a plurality of first cells 229, the second row 222 and the third row 224 may together define a plurality of second cells 230, the third row 224 and the fourth row 226 may together define a plurality of third cells 238, and the fourth row 226 and the fifth row 228 may together define a plurality of fourth cells 240. Cells 230, 238, 240 each correspond to the like-numbered cells in FIG. 4B.

[0142] In the illustrated example, the first cell 229 has a substantially diamond shape when the frame 200a or 200b is in the radially expanded configuration. The shapes of the cells 230, 238, and 240 correspond to the cells of the same number in FIG. 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) compared to the other cells (229, 238, and 240). In this example, the first cell 229 has the same number of cells as the second cell 230, the third cell 238, and the fourth cell 240 (e.g., nine cells for each of 229, 230, 238, and 240).

[0143] In some examples, the outflow end portion of the frame 200a or 200b can be further reinforced by adding one or more axial support struts bridging the diagonal struts of the second row 222 and the third row 224. For example, an axial support strut 225 (shown in dashed lines to indicate that it is optional) can connect and extend between a junction of two diagonal struts in the second row 222 (e.g., 208U in FIG. 8A or 208L in FIG. 8B ) and an axially aligned junction of two diagonal struts in the third row 224 such that a corresponding second cell 230 can be divided into two side-by-side halves. In some examples, each second cell 230 can include an axial support strut 225. In other examples, selected second cells 230 (e.g., every other second cell 230) can include an axial support strut 225.

[0144] Frame 200c, shown in FIG. 9A, is similar to frame 200a described above, except for the arrangement of outflow struts and the arrangement of the rows of support members. In contrast to frame 200a, which had two angled outflow struts 208 spanning each pair of adjacent axial frame members 210, frame 200c has four angled outflow struts 208' that extend between each pair of adjacent axial frame members 210. The outflow end 218' of frame 200c is defined by a row of support members 251' that are connected to and located downstream of the outflow struts 208'. As shown, the outflow struts 208' are joined at alternating upper and lower ends 208U' and 208L', with the upper ends 208U' axially located between the lower ends 208L' and the outflow end 218'. In the illustrated example, axial frame members 210 (including commissure supports 232 and axial posts 234) are connected to every other lower end 208L'.

[0145] Frame 200d shown in FIG. 9B is identical to 200c, except that each one of the axial frame members 210 (including the commissure supports 232 and the axial posts 234) is connected to every other upper end 208U.

[0146] Similarly, frame 200c or 200d has at least five rows of inclined struts, namely, a first row 221 formed by a row of support members 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.

[0147] In this example, the additional row of support members 251' can increase the strength of the outflow end portion of frame 200c or 200d. In some examples, the outflow end portion of frame 200c or 200c can be further reinforced by thickening and / or widening outflow struts 208' as described above. For example, the struts in the second row 222 of diagonal struts (outflow struts 208') can be wider than the diagonal struts in the other rows (221, 224, 226, 228). In some examples, the struts in the first row 221 of diagonal struts (row of support members 251') can have a smaller width than the diagonal struts in the other rows (222, 224, 226, 228). In some examples, the struts in the first row 221 of diagonal struts can have the same width as the struts in the second row 222, the third row 224, the fourth row 226, and / or the fifth row 228.

[0148] Similarly, frame 200c or 200d has at least four rows of cells, namely, a first cell 229' formed by the inclined struts of the first row 221 and the inclined struts of the second row 222, a second cell 230' formed by the inclined struts of the second row 222, the inclined struts of the third row 224 and the axial frame member 210, a third cell 238 formed by the inclined struts of the third row 224 and the inclined struts of the fourth row 226, and a fourth cell 240 formed by the inclined struts of the fourth row 226 and the inclined struts of the fifth row 228.

[0149] In Figures 9A-9B, the third cell 238 and the fourth cell 240 correspond to the cells of the same number in Figures 8A-8B, respectively. However, the first cell 229' and the second cell 230' can differ in size, shape, and / or number from the correspondingly numbered cells in Figures 8A-8B. For example, the number of the second cells 230' is the same as the third cells 238 and the fourth cells 240, but the number of the first cells 229' is twice as many as the number of the second cells 230'. In one embodiment, the number of the first cells 229' is 18 and the number of the second cells 230' is 9. Additionally, when the frame 200c or 200d is in a radially expanded configuration, the first cells 229' have a smaller area (e.g., less than 50%) than the third cells 238 and / or the fourth cells 240.

[0150] It will be understood that the frame configurations shown in Figures 8A-8B and 9A-9B are merely exemplary, and that 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 other than 2 (as in Figures 8A-8B) or 4 (as in Figures 9A-9B), such as, for example, 3, 5, 6, 7, 8, etc. A stage of support members defining the outflow end of the frame may be connected to and positioned downstream from the outflow struts to form a plurality of first cells. The ratio (R) of the number of first cells to the number of second cells may be N:2. For example, if N=3, then the ratio R is 3:2, if N=6, then the ratio R is 3:1, etc.

[0151] In some examples, the outflow end portion of the frame 200c or 200d can be further reinforced by adding one or more axial support struts bridging the diagonal struts of the second row 222 and the third row 224. For example, an axial support strut 225 (shown in dashed lines to indicate that it is optional) can connect and extend between a junction of two diagonal struts in the second row 222 (e.g., 208L' in FIG. 9A or 208U' in FIG. 9B ) and an axially aligned junction of two diagonal struts in the third row 224 such that a corresponding second cell 230' can be divided into two side-by-side halves. In some examples, each second cell 230' can include an axial support strut 225. In other examples, selected second cells 230' (e.g., every other second cell 230') can include an axial support strut 225.

[0152] Exemplary Frames with Alternative Support Structures 10-19 illustrate additional examples of frames that may be used in any of the prosthetic valves described herein (e.g., 10, 100, 150). As described in more detail below, each of the frames shown in FIGS. 10-19 has a support structure that includes two or more angled support arms and at least one axial support member. The support structure in these examples may divide the outflow cell of the frame into multiple sub-cells. Some of the sub-cells have a large area to facilitate coronary access through the interior. The support structure may prevent or limit the leaflets of the prosthetic valve from bulging outward through the large opening of the outflow cell during valve compression, and may also prevent or limit the native leaflets from protruding inward through the outflow cell during the cardiac cycle. The support structure may also reduce the risk of leaflet wear, for example, by eliminating apexes formed between the angled support arms (e.g., at the interface 254). Additionally, the axial support members within the support structure may improve the stability of the prosthetic valve and may prevent any portion of the support structure from protruding outward upon compression, thereby allowing unhindered axial movement of the prosthetic valve within the delivery catheter.

[0153] 10 and 10A-10B show an annular frame 300 for a prosthetic valve, according to one example. Similar to frame 260 in FIGS. 5A-5C, frame 300 includes four rows (e.g., rows 322, 324, 326, 328) of oblique struts 302. The first row 322 of oblique struts (also referred to as "outflow struts") defines an outflow end 318, and the fourth row 328 of oblique struts (also referred to as "inflow struts") defines an inflow end 316 of frame 300. Frame 300 also includes a number of axial frame members 310 bridging the oblique struts of first row 322 and the oblique struts of second row 324. In the example shown in FIG. 10, axial frame member 310 includes three commissure supports 332, each with a corresponding commissure window 336, and six axial posts 334. Two axial posts 334 are distributed circumferentially between each pair of adjacent commissure supports 332. The first row 322, the second row 324, and the axial frame member 310 may define a row of six-sided first cells 330 (also referred to as "outflow cells"). The second row 324, and the third row 326 may define a row of four-sided second cells 338. The third row 326, and the fourth row 328 may define a row of four-sided third cells 340 (also referred to as "inflow cells"). In the illustrated example, the frame 300 has nine first cells 330, nine second cells 338, and nine third cells 340.

[0154] The frame 300 also includes a plurality of support structures 350 connecting the plurality of axial frame members 310 and the diagonal struts of the second row 324. In the example illustrated in Figures 10 and 10A-10B, each support structure 350 includes two diagonal support arms 352 connecting two immediately adjacent axial frame members 310 and one axial support member 354 bridging the two diagonal support arms 352 and the diagonal struts of the second row 324. When the frame 300 is used in a prosthetic valve, an outer skirt (e.g., 18, 106, 156) can be attached to the diagonal support arms 352 of each support structure 350. For example, an outflow edge portion (e.g., 122, 152) of the outer skirt can be connected to the diagonal support arms 352 via sutures or other means.

[0155] The tilted support arms 352 may be similar to the arm portions 252 of the support member 250 described above. For example, each tilted support arm 352 may be connected to a corresponding axial frame member 310 at a connection point 358. As shown in FIG. 10A, two tilted support arms 352 located on either side of the axial frame member 310 of two adjacent support structures 350 may be connected to the axial frame member 310 at the connection points 358.

[0156] Each axial frame member 310 has an upper end 310U connected to an oblique strut in the first row 322 and a lower end 310L connected to an oblique strut in the second row 324. In some examples, as shown in Figures 10 and 10A-10B, the connection point 358 is axially spaced apart from the upper end 310U. In some examples, the connection point 358 can be located closer to the upper end 310U than the lower end 310L. In other examples, the upper end 310U can overlap the connection point 358.

[0157] For each support structure 350, the two inclined support arms 352 and the axial support member 354 are connected at a junction 356 such that the two inclined support arms 352 and the axial support member 354 may define a Y-shaped configuration. The junction 356 may define an upper end of the axial support member 354. As shown in FIG. 10A, each Y-shaped support structure 350 may divide the corresponding effusion cell 330 into three openings or subcells, i.e., one upper subcell 330U and two lower subcells 330L. In the illustrated example, the frame 300 has nine upper subcells 330U and eighteen lower subcells 330L. Each upper subcell 330U has a width that is twice the width of the lower subcell 330L.

[0158] 10 and 10A-10B, each upper subcell 330U is six sided and is defined by two diagonal strut portions 304 of the diagonal struts in the first row 322, two diagonal support arms 352, and two upper portions 312 of the two axial frame members 310. In other examples, each upper cell 330U can be four sided. For example, when the upper ends 310U overlap the connection points 358, each upper subcell 330U is defined by two diagonal strut portions 304 of the diagonal struts in the first row 322 and two diagonal support arms 352.

[0159] 10A, the diagonal struts of the second row 324 are joined at alternating upper and lower ends 324U, 324L (the upper ends 324U being closer to the outflow end 318 than the lower ends 324L). The axial support members 354 may be connected to the corresponding lower ends 324L of the diagonal struts of the second row 324. Thus, the lower ends 324L of the diagonal struts in the second row 324 may 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.

[0160] In some examples, the angled support arms 352 can be substantially parallel to corresponding angled struts in the second row 324. Thus, each of the lower subcells 330L can have a parallelogram shape.

[0161] Each support structure 350 can be configured to be axially foldable. For example, similar to arm portion 252 in FIGS. 5A-5C, each pair of angled support arms 352 can be folded at joint portion 356 when frame 300 transitions from a radially expanded configuration (see, e.g., FIG. 10A) to a radially compressed configuration (see, e.g., FIG. 10B). When folded, the two angled support arms 352 of each support structure 350 can extend between and substantially parallel to two immediately adjacent axial frame members 310. In addition, axial support members 354 can move axially when frame 300 transitions from a radially expanded configuration to a radially compressed configuration.

[0162] With respect to the angled support arms 352 and the angled struts of the second row 324, the axial support members 354 can eliminate the free apexes where the support arms 352 cross over one another, thereby reducing the risk of leaflet abrasion. The Y-shaped support structures 350 can also be confined within a plane defined by the corresponding outflow cells 330 (e.g., preventing any portion of the support structures 350 from protruding outward when the frame 300 is compressed), thereby improving the stability of the frame 300 (and the corresponding prosthetic valve). Additionally, the Y-shaped support structures 350 can act as a barrier to prevent the leaflets of the prosthetic valve from bulging outward and / or to prevent the native leaflets from protruding inward through the outflow cells 330.

[0163] In some instances, the angled support arms 352 are narrower than the angled struts 302 within any row of angled struts (e.g., 322, 324, 326, 328). In some instances, the axial support members 354 are narrower than the axial frame members 310 (including the commissure supports 332 and axial posts 334).

[0164] In some examples, the angled support arm 352 is narrower in width than the axial support member 354. In other examples, the angled support arm 352 can have about the same width as the axial support member 354.

[0165] 10A also illustrates the relative position of a leaflet (e.g., 40 or 104) and frame 300 after attachment of the leaflet to the frame 300 (the outer periphery of the leaflet is shown in dashed lines), according to one example. As shown, the leaflet's outflow edge 42 can extend across the three outflow cells 330. The axial location 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 a leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly that is inserted into the corresponding commissure window 336. The leaflet's pointed edge 46 (located below the commissure tab 44 and opposite the outflow edge 42) can have a generally V-shaped profile. The sharpened edge 46 may extend along and be attached to four angled struts (e.g., 324a, 324b, 326a, and 326b) located on the second row 324 and on the third row 326, and two angled strut portions (e.g., 306a and 306b) located on the fourth row 328. The apex region 48 of the leaflet may be aligned with a curved apex portion 307 of the inflow strut (similar to 207 in FIGS. 5A-5B ) at the inflow end 316 of the frame 300.

[0166] 11 illustrates a cross-section of an annular frame 400 for a prosthetic valve, according to another example, with the frame portions shown in a flattened configuration. The overall frame 400 includes three such frame portions. Frame 400 is similar to frame 300, except that frame 400 has five rows of angled struts 402 (e.g., rows 422, 424, 426, 428, 429). In some examples, frame 400 can have a larger diameter compared to frame 300 when both frames 300, 400 are in a radially expanded configuration. In some examples, frames similar to 300 and 400 can have six or more rows of angled struts.

[0167] In the example shown in FIG. 11 , the first row 422 of diagonal struts define the outflow end 418 of the frame 400, and the fifth row 429 of diagonal struts define the inflow end 416 of the frame 400. Similar to the frame 300, the frame 400 includes a plurality of axial frame members 410 bridging the first row 422 of diagonal struts with the second row 424 of diagonal struts. For example, the axial frame members 410 may include three commissure supports 432, each with a corresponding commissure window 436, and nine axial posts 434. The three axial posts 434 may be circumferentially distributed between two adjacent commissure supports 432. The first row 422 of diagonal struts, the second row 424 of diagonal struts, and the axial frame members 410 may define a row of six-sided outflow cells 430. The diagonal struts of the fourth row 428 and the diagonal struts of the fifth row 429 may define a row of four sided inflow cells 442. The diagonal struts of the second row 424, the diagonal struts of the third row 426 and the diagonal struts of the fourth row 428 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 12.

[0168] The frame 400 also includes a number of support structures 450 that are similar to the support structure 350 shown in Figures 10 and 10A-10B. For example, each support structure 450 has two inclined support arms 452 connecting two immediately adjacent axial frame members 410 and one axial support member 454 bridging the two inclined support arms 452 and the inclined struts of the second row 424. Similarly, each support structure 450 can divide the effusion cell 430 into one upper subcell 430U and two lower subcells 430L. As a result, the frame 400 has 12 upper subcells 430U and 24 lower subcells 430L.

[0169] 11 also illustrates the relative positions of a leaflet (e.g., 40 or 104) and frame 400 after the leaflet is attached to the frame 400 (the outer periphery of the leaflet is shown in dashed lines), according to one example. As shown, the outflow edge 42 of the leaflet can extend across the 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 a leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly that is inserted into the corresponding commissure window 436. The leaflet's sharp edge 46 may extend along and be attached to six angled struts (e.g., 424a, 424b, 426a, 426b, 428a, 428b) located on the second, third, and fourth rows 424, 426, and 428, and two angled strut portions (e.g., 406a and 406b) located on the fifth row 429. The leaflet's apex region 48 may be aligned with the inflow strut's curved apex portion 407 (similar to 207 in FIGS. 5A-5B ) at the inflow end 416 of the frame 400.

[0170] 12 illustrates a cross-section of an annular frame 500 for a prosthetic valve, according to another example, shown in a flattened configuration. The entire frame 500 includes three such sections. Frame 500 is similar to frame 300, except that frame 500 only has three rows of angled struts 502 (e.g., 522, 524, 526). In some examples, frame 500 can have a smaller diameter compared to frame 300 when both frames 300, 500 are in a radially expanded configuration.

[0171] In the example shown in FIG. 12, the first row 522 of diagonal struts define the outflow end 518 of the frame 500, and the third row 526 of diagonal struts define the inflow end 516 of the frame 500. Similar to the frame 300, the frame 500 includes a plurality of axial frame members 510 bridging the first row 522 of diagonal struts with the second row 524 of diagonal struts. For example, the axial frame members 510 may include three commissure supports 532, each with a corresponding commissure window 536, and three axial posts 534. Each axial post is circumferentially disposed between two adjacent commissure supports 532. The first row 522 of diagonal struts, the second row 524 of diagonal struts, and the axial frame members 510 may define a row of six-sided outflow cells 530. The angled struts of the second row 524 and the angled struts of the third row 526 can 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.

[0172] The frame 500 also includes a number of support structures 550 that may be similar to the support structure 350 shown in Figures 10 and 10A-10B. For example, each support structure 550 may have two inclined support arms 552 connecting two immediately adjacent axial frame members 510 and one axial support member 554 bridging the two inclined support arms 552 and the inclined struts of the second row 524. Similarly, each support structure 550 may divide the effusion cell 530 into one upper subcell 530U and two lower subcells 530L. As a result, the frame 500 includes six upper subcells 530U and twelve lower subcells 530L.

[0173] 12 also illustrates the relative positions of a leaflet (e.g., 40 or 104) and frame 500 after attachment of the leaflet to the frame 500 (the outer periphery of the leaflet is shown in dashed lines), 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 a leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly that is inserted into the corresponding commissure window 536. The leaflet's sharp edge 46 may extend along and be attached to two angled struts (e.g., 524a, 524b) in the second row 524 and two angled strut portions (e.g., 506a and 506b) in the second row 526. The leaflet's apex region 48 may be aligned against a curved apex portion 507 of the inflow strut (similar to 207 in FIGS. 5A-5B ) at the inflow end 516 of the frame 500.

[0174] 13 shows another example of a cross section of a frame 500' similar to the frame 500, except that the frame 500' includes additional diagonal support members 540, 542 interconnected to the third row of diagonal struts 526. Six diagonal support members 540 are positioned relative to the inflow cell 538, each of which bridges two diagonal strut portions (e.g., 506a and 506b) of a corresponding inflow strut. Six other diagonal support members 542 are positioned outside the inflow cell 538, each of which bridges a diagonal strut portion (e.g., 506a or 506b) of one inflow strut with an adjacent diagonal strut portion of an adjacent inflow strut. Each diagonal support member 540 has an arc angle A1 oriented toward the inflow end 516, and each diagonal support member 542 has an arc angle A2 oriented toward the outflow end 518. When the frame 500' is in the radially expanded configuration, the arc angle A1 can be smaller than the arc angle A2. Each angled support member 540 can divide the corresponding inflow cell 538 into an upper subcell 538U and a lower subcell 538L. Each angled support member 542 can bridge two adjacent angled strut portions to form an additional lower subcell 538L'.

[0175] 14 shows another example one-third cross section of an annular frame 600 for a prosthetic valve, according to another embodiment. Similar to frame 300, frame 600 includes four rows (e.g., rows 622, 624, 626, 628) of oblique struts 602, where the oblique struts of the first row 622 define the outflow end 618 of the frame 600 and the oblique struts of the fourth row 628 define the inflow end 616 of the frame 600. Similarly, frame 600 includes a plurality of axial frame members 610 (e.g., three commissure supports 632, each with a corresponding commissure window 636, and six axial posts 634) bridging the oblique struts of the first row 622 and the oblique struts of the second row 624. The diagonal struts of the first row 622, the diagonal struts of the second row 624, and the axial frame member 610 may define a row of six sided outflow cells 630. The diagonal struts of the second row 624 and the diagonal struts of the third row 626 may define a middle row of four sided cells 638. The diagonal struts of the third row 626 and the diagonal struts of the fourth row 628 may define a row of six sided inflow cells 640.

[0176] The frame 600 also includes a number of support structures 650. Each support structure 650 has two inclined support arms 652 connecting two immediately adjacent axial frame members 610 and an axial support member 654 bridging the two inclined support arms 652 and an inclined strut of the second row 624. Unlike the frame 300, in which the axial support members 354 terminate at the corresponding lower ends 324L of the inclined struts in the second row 324, the axial support members 654 of the frame 600 extend further downward (towards the inflow end 616) and bridge the inclined struts of the second row 624 and the inclined struts (i.e., the inflow struts) of the fourth row 628. As a result, each axial support member 654 can divide a corresponding six-sided inflow cell 640 into two four-sided subcells 640a, 640b. The inflow struts of the frame 600 (at the fourth row 628) form a zigzag pattern and define a number of upper ends 628U downstream from the inflow end 616. The axial support members 654 of the support structure 650 connect the lower ends 624L of the diagonal struts of the second row 624 to the corresponding upper ends 628U of the inflow struts. Each of the remaining upper ends 628U of the inflow struts are connected to two diagonal struts in the third row 626. In this example, the ratio of the number of apexes 605 defined by the outflow struts to the number of apexes 607 defined by the inflow struts is 1:2.

[0177] 14 also illustrates the relative positions of a leaflet (e.g., 40 or 104) and frame 600 after attachment of the leaflet to the frame 600 (the outer periphery of the leaflet is shown in dashed lines), according to one example. As shown, the outflow edge 42 of the leaflet can extend across the three outflow cells 630. The axial position of the outflow edge 42 can be 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 a leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly that is inserted into the corresponding commissure window 636. The leaflet sharp edge 46 may 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 on the third row 626. In some examples, the leaflet sharp edge 46 may also be attached to two angled strut portions (e.g., struts 606a, 606b) of the inflow strut. Alternatively, the leaflet sharp edge 46 may be detached from the inflow strut. The leaflet apex region 48 may be located at the inflow end 616 of the frame 600. In the example illustrated in FIG. 14, the leaflet apex region 48 is not connected to any struts of the frame 600. The leaflet apex 49 may be located upstream of the junction 625 where the axial support member 654 is connected to the inflow strut.

[0178] 15 shows a one-third cross section of another example annular frame 700 for a prosthetic valve. Frame 700 has four rows (e.g., rows 722, 724, 726, 728) of angled struts 702, where the first row 722 of angled struts defines the outflow end 718 of the frame 700 and the fourth row 728 of angled struts defines the inflow end 716 of the frame 700. The top half of the frame (near the outflow end 718) and the bottom half of the frame (near 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 frame members 310) bridging the diagonal struts of the first row 722 and the diagonal struts of the second row 724, and a plurality of second axial frame members 710' (mirror images of the corresponding first axial frame members 710) bridging the diagonal struts of the third row 726 and the diagonal struts of the fourth row 728. Additionally, 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 diagonal support arms 752 connecting two immediately adjacent first axial frame members 710 and one axial support member 754 bridging the two diagonal support arms 752 and the diagonal struts of the second row 724. Each second support structure 750' has two inclined support arms 752' connecting two immediately adjacent second axial frame members 710' and one axial support member 754' bridging the two inclined support arms 752' and an inclined strut of the third row 726. 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 junctions 760 between the inclined struts of the second row 724 and the inclined struts of the third row 726 such that each first support structure 750 is a mirror image of the corresponding second support structure 750'.

[0179] 16 illustrates a third cross-section of an annular frame 800 for a prosthetic valve according to another example. The frame 800 has four rows (e.g., rows 822, 824, 826, 828) of oblique struts 802. The first row 822 of oblique struts defines an outflow end 818 of the frame 800, and the fourth row 828 of oblique 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, each with a corresponding commissure window 836, and three axial posts 834) bridging the first row 822 of oblique struts and the second row 824 of oblique struts. The first row 822 of oblique struts, the second row 824 of oblique struts, the axial frame members 810, and an eight-sided outflow cell 830 may be defined. The diagonal struts of the second row 824 and the diagonal struts of the third row 826 can define a middle row of four sided cells 838. The diagonal struts of the third row 826 and the diagonal struts of the fourth row 828 can 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.

[0180] The frame 800 also includes a number of support structures 850. As shown in FIG. 16, each support structure 850 may have four inclined support arms 852 interconnected to define a W-shaped configuration. The four inclined support arms 852 may include two side support arms 852a connected to two adjacent axial frame members 810, respectively, and two middle support arms 852b disposed between the two side support arms 852a. The inclined struts of the second row 824 are joined alternately at upper ends 824U and lower ends 824L. Each support structure 850 further includes a middle axial support member 854 connecting joints 856 of the two middle support arms 852b to the corresponding upper ends 824U of the inclined struts of the second row 824. As a result, each support structure 850 can divide the corresponding effusion cell 830 into an upper subcell 830U and two lower subcells 830L. As shown in FIG. 16, each lower subcell 830L has six sides, and the upper subcell 830U has twice the width compared to the width of each lower subcell 830L. In the example shown in FIG. 16, each side support arm 852a is connected to an adjacent axial frame member 810 at a connection point 858 axially spaced from the upper end 810U of the axial frame member 810. In other examples, the connection point 858 can overlap the upper end 810U.

[0181] 16 also illustrates the relative positions of a leaflet (e.g., 40 or 104) and frame 800 after attachment of the leaflet to the frame 800 (the outer periphery of the leaflet is shown in dashed lines), 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 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 a leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly that is inserted into the corresponding commissure window 836. The leaflet sharp edge 46 may 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 on the third row 826. In some examples, the leaflet sharp edge 46 may also be attached to two angled strut portions (e.g., 806a and 806b) of the inflow strut. Alternatively, the leaflet sharp edge 46 may be detached from the inflow strut. The leaflet apex region 48 may be located at the inflow end 816 of the frame 800. In the example illustrated in FIG. 16, the leaflet apex region 48 is not connected to any struts of the frame 800. The leaflet apex 49 may be located upstream of the junction 825 where the angled struts of the third row 826 connect to the angled struts of the fourth row 828.

[0182] FIG. 17 shows a third cross-section of an annular frame 800' for a prosthetic valve according to another embodiment. The frame 800' is similar to the frame 800, except that the frame 800' has a different support structure 850'. As shown in FIG. 17, each support structure 850' also has four oblique support arms 852 (including two side support arms 852a and two middle support arms 852b) interconnected to define a W-shaped configuration, and one middle axial support member 854 connecting the joints 856 of the two middle support members 852b to the corresponding upper ends 824U of the oblique struts of the second row 824. Additionally, each support structure 850' further includes two side axial support members 855 located on either side of the middle support member 854. Each side axial support member 855 can connect one of the lower ends 824L of the inclined struts of the second row 824 to a joint 853 formed between a side support arm 852a and an adjacent middle support arm 852b. As a result, each support structure 850' can divide the corresponding outflow cell 830 into an upper subcell 830U and four lower subcells 830L. Each of the lower subcells 830L has a width that is quartered compared to the width of the upper subcell 830U. As shown, each of the lower subcells 830L can have a parallelogram shape.

[0183] 18 illustrates a third cross-section of an annular frame 900 for a prosthetic valve according to another example. The frame 900 has five rows (e.g., rows 922, 924, 926, 928, 929) of oblique struts 902. The oblique struts of the first row 922 define an outflow end 918 of the frame 900, and the oblique struts of the fifth row 929 define 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, each with a corresponding commissure window 936, and three axial posts 934) bridging the oblique struts of the first row 922 and the oblique struts of the second row 924.

[0184] In this example, the diagonal struts in the second row 924 are discontinuous, while the corresponding diagonal struts in the other four rows (rows 922, 926, 928, 929) are interconnected to form a circumferentially continuous row of diagonal struts. For example, as shown in FIG. 18, two diagonal struts 924c, 924d in the second row 924 may be connected to the lower end 910L of the corresponding axial frame member 910. However, the same two diagonal struts 924c, 924d are not directly connected to any other diagonal struts (e.g., 924a, 924b) in the second row 924. In this example, the second row 924 has only 12 diagonal struts, while the third row 926 and the fourth row 928 each have 24 diagonal struts.

[0185] In the example shown in FIG. 18, the first row 922, the second row 924, the third row 926, and the axial frame member 910 may define a row of six sided outflow cells 930. The second row 924 and the third row 926 may define an upper intermediate row of four sided cells 938. The third row 826 and the fourth row 828 may define a lower intermediate row of four sided cells 940. The fourth row 928 and the fifth row 928 may 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 diagonal struts in the second row 924, each cell 938 in the upper middle row is not directly connected to any other cell 938 in the upper middle row.

[0186] The frame 900 also includes a plurality of support structures 950 connecting the plurality of axial frame members 910 and the diagonal struts of the second row 924 and the diagonal struts of the third row 926. In this example, each support structure 950 includes two diagonal support arms 952 connecting two immediately adjacent axial frame members 910 and three axial support members 954 bridging the two diagonal support arms 952 and the diagonal struts of the second row 924 and the diagonal struts of the third row 926. As shown in FIG. 18, the three axial support members 954 include one middle axial support member 954b and two side axial support members 954a. The middle axial support member 954b has an upper end connected to the junctions 956 of the two diagonal support arms 952. The two side axial support members 954a have respective upper ends connected to respective midpoints 957 of the two oblique support arms 952 (i.e., each side axial support member 954a bisects a respective oblique support arm 952). Additionally, each support structure 950 further includes a connecting support member 951 connecting the midpoints 957 of the two oblique support arms 952. For prosthetic valves 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 oblique support arms 952 and / or a portion of the connecting support member 951).

[0187] In some examples, the angled support arms 952 and connecting support members 951 are narrower than the outflow struts (in the first row 922) and inflow struts (in the fifth row 929). In some examples, the axial support members 954 are narrower than the axial frame members 910.

[0188] 18, two inclined support arms 952 located on either side of the axial frame member 910 of two adjacent support structures 950 can be connected to the axial frame member 910 at a connection point 958. In the illustrated example, the connection point 958 is axially spaced apart from the upper end 910U of the axial frame member 910. In another example, the upper end 910U of the axial frame member 910 can overlap the connection point 958.

[0189] The diagonal struts of the third row 926 are joined at alternating upper and lower ends 926U, 926L. Each diagonal strut in the second row 924 is connected to one of the upper ends 926U of the diagonal struts of the third row 926. As shown in FIG. 18, for each support structure 950, the lower end of the middle axial support member 954b can be connected to one of the lower ends 926L of the diagonal struts of the third row 926, and the lower end of each side axial support member 954a can be connected to one of the upper ends 926U of the diagonal struts of the third row 926.

[0190] In the example shown in FIG. 18, each support structure 950 can divide the corresponding effusion cell 930 into six subcells, including a row of four lower subcells 930L arranged in a V-shaped pattern, one middle subcell 930M, and one upper subcell 930U. Each of the four lower subcells 930L has a parallelogram shape. The middle subcell 930M has four sides. The upper subcell 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 six sides (if the upper end 910U of the axial frame member 910 overlaps the connection point 958).

[0191] 18 also illustrates the relative positions of a leaflet (e.g., 40 or 104) and frame 900 after attachment of the leaflet to the frame 900 (the outer periphery of the leaflet is shown in dashed lines), 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 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 a leaflet can be paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly that is inserted into the corresponding commissure window 936. The leaflet's sharp edge 46 may extend along and be attached to 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, and two angled strut portions (e.g., struts 906a, 906b) located on the fifth row 929. The leaflet's apex region 48 may be aligned against a curved apex portion 907 of the inflow strut (similar to 207 in FIGS. 5A-5B ) at the inflow end 916 of the frame 900.

[0192] 19 shows a one-third cross section of an annular frame 900' for a prosthetic valve, according to another example. Similar to frame 900, frame 900' has five rows (e.g., 922, 924, 926, 928, 929) of angled struts 902, with the first row 922 of angled struts defining an outflow end 918 of the frame 900 and the fifth row 929 of angled struts defining an inflow end 916 of the frame 900. Frame 900' also includes a plurality of axial frame members 910 bridging the first row 922 and the second row 924 of angled struts. Unlike frame 900, axial frame member 910 of frame 900' includes three commissure supports 932, but does not include axial posts (e.g., post 934) located between the commissure supports 932 to bridge the diagonal struts of the first row 922 and the second row 924. As with frame 900, the diagonal struts in each of the other four rows (922, 926, 928, 929) are interconnected to form a circumferentially continuous row of diagonal struts, but the diagonal struts in the second row 924 are discontinuous. In this example, the second row 924 has only six diagonal struts, while the third row 926 and fourth row 928 each have 24 diagonal struts.

[0193] In the example shown in FIG. 19 , the first row 922, the second row 924, the third row 926, and the axial frame member 910 may define a row of twelve sided outflow cells 930. The second row 924 and the third row 926 may define an upper intermediate row of four sided cells 938 (located directly below the corresponding commissure support 932). The third row 826 and the fourth row 828 may define a lower intermediate row of four sided cells 940. The fourth row 928 and the fifth row 928 may define a row of four sided inflow cells 942. In this example, due to the lack of axial posts, there are only three outflow cells 930 and three cells 938 in the upper middle row, while there are twelve cells 940 and twelve inflow cells 942 in the lower middle row. Due to the discontinuity of the angled struts in the second row 924, the cells 938 in the upper middle row are not directly connected to each other.

[0194] The frame 900' may have three support structures 950' connecting the three axial frame members 910 and the diagonal struts of the second row 924 and the diagonal struts of the third row 926. As shown in FIG. 19, each support structure 950' includes eight diagonal 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 diagonal support arms 952 and a lower end connected to a corresponding upper end 926U of the diagonal strut of the third row 926. In this example, each support structure 950 may divide the corresponding effluent cell 930 into seven subcells, including a row of five lower subcells 930L' and two upper subcells 930U'. The five lower subcells 930L' include three six-sided subcells 930a positioned between two four-sided subcells 930b (each having a parallelogram shape).

[0195] Exemplary Expansion Mechanisms for Prosthetic Valves For any of the prosthetic valves described herein, the frame can be made from any of a variety of suitable plastically expandable materials. When constructed from a plastically expandable material, the frame (and thus the prosthetic valve) can be compressed into a radially collapsed configuration on a delivery catheter or on a delivery device, and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. In certain instances, upon delivery to the implantation site, the prosthetic valve can be placed inside a delivery capsule or delivery sheath to protect the prosthetic valve from contact with the patient's vasculature, such as when the prosthetic valve is driven forward through the femoral artery. The capsule can also prevent any recoil (expansion) of the frame after the prosthetic valve is compressed onto the delivery device, thereby holding the prosthetic valve in a radially compressed state with a slightly smaller diameter and compression profile than would be possible without the capsule.

[0196] Suitable plastically expandable materials that may be used to form any of the frames disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys may include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, the frame may include stainless steel. In some examples, the frame may include cobalt chromium. In some examples, the frame may include nickel-cobalt-chromium. In some examples, the frame may include nickel-cobalt-chromium-molybdenum alloys, such as MP35N® (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N® / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0197] Additional details regarding balloon-expandable prosthetic valves can be found in U.S. Patent No. 9,393,110, U.S. Provisional Application No. 63 / 178,416, filed April 22, 2021, U.S. Provisional Application No. 63 / 194,830, filed May 28, 2021, and U.S. Provisional Application No. 63 / 279,096, filed November 13, 2021, all of which are incorporated by reference into this specification.

[0198] Any of the prosthetic valves described herein can be self-expandable. For example, the frame of the prosthetic valve can include a shape memory material (e.g., Nitinol). When the prosthetic valve is self-expandable, the frame (and thus the prosthetic valve) can be compressed into a radially compressed configuration by insertion into a sheath of a delivery catheter or into an equivalent mechanism, and can be constrained in the compressed configuration. Once within the body at the desired implantation site, the prosthetic valve can be deployed or released from the delivery sheath, which allows the prosthetic valve to expand to its functional size. In some examples, the frame (and thus the prosthetic valve) can partially self-expand from the radially compressed configuration to a partially radially expanded configuration. The frame (and thus the prosthetic valve) can be further radially expanded from the partially expanded configuration to a further radially expanded configuration via one or more drive assemblies (e.g., an inflatable balloon and / or one or more mechanical actuators) of the delivery device.

[0199] Additional details regarding exemplary self-expanding prosthetic valves and related delivery devices / catheters / systems are provided in U.S. Pat. Nos. 8,652,202, 9,155,619, and 9,867,700, all of which are incorporated herein by reference.

[0200] 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 one another at one or more pivot joints along the length of each strut. As a result, the prosthetic valve can be radially expanded or compressed by an axial force applied to the frame (e.g., pressing the inflow and outflow ends of the frame toward one another or pulling the inflow and outflow ends of the frame away from one another). The axial force can be generated by actuating one or more mechanical actuators in a delivery device operably coupled to the frame.

[0201] Additional details regarding exemplary mechanically expandable prosthetic valves and related delivery devices / catheters / systems are provided in U.S. Patent Application Publication No. 2018 / 0153689, U.S. Patent Application Publication No. 2018 / 0311039, U.S. Patent Application Publication No. 2019 / 0060057, and PCT Patent Application Publication No. WO / 2021 / 188476, all of which are incorporated by reference herein.

[0202] Exemplary Delivery Devices 20 illustrates a delivery device 1000, according to one example, that may be used to implant an expandable prosthetic valve (e.g., prosthetic valves 10, 100, 150, and / or any other prosthetic valve described herein). In some examples, the delivery device 300 may be specifically configured for use in introducing a prosthetic valve into the heart.

[0203] 20 is a balloon catheter and includes a handle 1002 and a steerable outer shaft 1004 extending distally from the handle 1002. The delivery device 1000 may further include an intermediate shaft 1006 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 1002, the portion extending distally from the handle 1002 also extending coaxially through the outer shaft 1004. Additionally, the delivery device 1000 may further include 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.

[0204] The outer shaft 1004 and the intermediate shaft 1006 can be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 1020 of the delivery device 1000 to facilitate delivery and positioning of the prosthetic valve to an implantation site within a patient's body.

[0205] The midshaft 1006 can include a proximal end portion 1010 that extends proximally from the proximal end of the handle 1002 to the adapter 1012. A rotatable knob 1014 can be mounted on the proximal end portion 1010 and can be configured to rotate the midshaft 1006 relative to the outer shaft 1004 about a central longitudinal axis 1020.

[0206] The adapter 1012 can include a first port 1038 configured to receive a guidewire therethrough and a second port 1040 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 1040 can be fluidly coupled to an inner lumen of the midshaft 1006.

[0207] The midshaft 1006 can further include a distal end 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 inflatable balloon 1018 of the delivery device 1000. The distal end portion of the inner shaft 1008 can extend distally beyond the distal end portion of the midshaft 1006.

[0208] The balloon 1018 can be coupled to a distal end portion of the midshaft 1006 .

[0209] In some examples, the distal end of the balloon 1018 can be coupled to the distal end of the delivery device 1000, such as a nose cone 1022, or to an alternative component at the distal end of the delivery device 1000 (e.g., a distal shoulder). An intermediate portion of the balloon 1018 can cover a valve mounting portion 1024 at the distal end portion of the delivery device 1000, and a distal end portion of the balloon 1018 can cover a distal shoulder 1026 of the delivery device 1000. The valve mounting portion 1024 and the intermediate portion of the balloon 1018 can be configured to receive a prosthetic valve in a radially compressed state. For example, as shown generally in FIG. 20, a prosthetic valve 1050 (which can be one of the prosthetic valves described herein) can be attached to the periphery of the balloon 1018 at the valve mounting portion 1024 of the delivery device 1000.

[0210] The balloon shoulder assembly, including the distal shoulder 1026, can be configured to maintain the prosthetic valve 1050 (or other medical device) in a fixed position on the balloon 1018 during delivery through the patient's vasculature.

[0211] The outer shaft 1004 can include a distal tip portion 1028 mounted on its distal end. The outer shaft 1004 and the intermediate shaft 1006 can be axially translated relative to one another to position the distal tip portion 1028 adjacent a proximal end of the valve mounting portion 1024 when the prosthetic valve 1050 is mounted in radial compression on the valve mounting portion 1024 (as shown in FIG. 20 ) and during delivery of the prosthetic valve to a target implantation site. In this manner, the distal tip portion 1028 can be configured to resist movement of the prosthetic valve 1050 in an axially proximal direction relative to the balloon 1018 when the distal tip portion 1028 is positioned adjacent a proximal side of the valve mounting portion 1024.

[0212] An annular space can be defined between an outer surface of the inner shaft 1008 and an inner surface of the midshaft 1006, and the annular space 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 passageway formed between an outer surface of the distal end portion of the inner shaft 1008 and an inner surface of the balloon 1018. In this manner, fluid from the fluid source can flow from the annular space to the fluid passageway, thereby inflating the balloon 1018 to radially expand and deploy the prosthetic valve 1050.

[0213] The lumen of the inner shaft can be configured to receive a guidewire therethrough for steering the distal end portion of the delivery device 1000 to the target implantation site.

[0214] The handle 1002 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 1000. In the illustrated example, for example, the handle 1002 includes an adjustment member, such as the illustrated rotatable knob 1060, which can be operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 1002 through the outer shaft 1004 and have a distal end portion fixed relative to the outer shaft 1004 at or near the distal end of the outer shaft 1004. By rotating the knob 1060, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 1000. Further details regarding steering or bending mechanisms in delivery devices can be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0215] The handle 1002 can further include an adjustment mechanism 1061, including an adjustment member, such as the illustrated rotatable knob 1062, and an associated 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 middle shaft 1006 relative to the outer shaft 1004 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 1000 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0216] Although the delivery device 1000 illustrated in FIG. 20 is particularly adapted for delivering a balloon-expandable prosthetic valve, it will be understood that variations of the delivery device 1000 may be configured to deliver a self-expandable prosthetic valve and / or to deliver a mechanically expandable prosthetic valve, as described in the above-incorporated documents.

[0217] Exemplary Delivery Techniques To implant the prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve can be mounted in radial compression along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device can be inserted into the femoral artery and driven forward into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve can be positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by driving one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve can be positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) can be introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then driven forward through the ascending aorta toward the native aortic valve.

[0218] To implant the prosthetic valve inside the native mitral valve via a transseptal delivery approach, the prosthetic valve can be mounted in radial compression along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device can be inserted into the femoral vein, and then driven forward into the inferior vena cava and through the inferior aorta, into the right atrium, across the atrial septum (e.g., through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted inside the native mitral valve in a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve can be positioned inside the native mitral valve.

[0219] To implant the prosthetic valve inside the native tricuspid valve, the prosthetic valve can be mounted in radial compression along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device can be inserted into the femoral vein and then driven forward into and through the inferior vena cava into the right atrium, where the prosthetic valve can be positioned inside the native tricuspid valve. A similar approach can be used to implant the prosthetic valve inside the native pulmonary valve or pulmonary artery, except that the prosthetic valve can be driven forward through the native tricuspid valve into the right ventricle and toward the pulmonary valve / artery.

[0220] Another delivery approach is a transatrial approach, where the prosthetic valve (on the distal end portion of the delivery device) can be inserted through an incision in the chest and through an incision made through the atrial wall (the atrial wall of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery approach is a transventricular approach, where the prosthetic valve (on the distal end portion of the delivery device) can be inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve or within the native pulmonary valve or within the pulmonary artery.

[0221] In all delivery approaches, the delivery device can be driven forward over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0222] It will be understood that the treatment techniques, methods, steps, etc., as described or suggested herein, or as described or suggested in the references incorporated herein, may be performed on live animals or may be performed on non-biological simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., in which body parts, tissues, etc. are simulated), and the like.

[0223] sterile Any of the systems, devices, apparatus, etc. herein may be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any of the methods herein may include sterilizing the associated system, device, apparatus, etc. as one of the method steps. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet light, and electron beam. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be performed, for example, using hydrogen peroxide plasma.

[0224] Additional Examples of the Disclosed Technology In view of the above implementations of the disclosed subject matter, the present application discloses additional examples, which are listed below. It should be noted that each feature in an example individually, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also additional examples falling within the disclosure of the present application.

[0225] Example 1. 1. An artificial valve comprising: an annular frame radially collapsible to a collapsed configuration and radially expandable to an expanded configuration; and an outer skirt disposed on an outer surface of the annular frame, the annular frame comprising: an inflow end; an outflow end; a first row of oblique struts defining the outflow end; a second row of oblique struts located closer to the inflow end than the first row of oblique struts; a plurality of axial frame members bridging the first row of oblique struts and the second row of oblique struts; and a plurality of support members connecting the plurality of axial frame members, the support members being narrower than the axial frame members, the first row of oblique struts, and the second row of oblique struts, the outer skirt being connected to the support members.

[0226] Example 2. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 1, further comprising a leaflet structure disposed within the annular frame and configured to permit blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end.

[0227] Example 3. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 2, further comprising an inner skirt attached to an inner surface of the annular frame, the leaflet structure being connected to the inner skirt.

[0228] Example 4. A prosthetic valve as described in any embodiment herein, particularly as described in embodiment 2 or 3, wherein the plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial posts located between every two immediately adjacent commissure supports, each commissure support configured to support a corresponding commissure of the leaflet structure.

[0229] Example 5. The prosthetic valve as described in any embodiment herein, particularly embodiment 4, wherein the leaflet structure includes three leaflets defining three commissures, and the plurality of axial frame members includes three axially extending commissure supports.

[0230] Example 6. 13. The prosthetic valve as described in any embodiment herein, in particular as described in embodiment 4 or 5, wherein two axial posts are provided located between every two immediately adjacent commissural supports.

[0231] Example 7. An artificial valve as described in any embodiment herein, particularly any one of embodiments 1 to 6, wherein the first row of oblique struts and the second row of oblique struts have a narrower width compared to the plurality of axial frame members.

[0232] Example 8. The prosthetic valve according to any of the embodiments herein, in particular any one of embodiments 1 to 7, wherein the second row of oblique struts has a narrower width than the first row of oblique struts.

[0233] Example 9. An artificial valve as described in any embodiment herein, particularly any one of embodiments 1-8, wherein the first row of oblique struts are joined at a first set of alternating upper and lower ends, the upper ends defining an outflow end and the lower ends being located closer to the inflow end than the upper ends, the second row of oblique struts are joined at a second set of alternating upper and lower ends, the upper ends being located closer to the outflow end than the lower ends, and a plurality of axial frame members each connect the lower ends of the first row of oblique struts to the upper ends of the second row of oblique struts.

[0234] Example 10. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 9, wherein each support member is connected to the upper ends of two immediately adjacent axial frame members.

[0235] Example 11. An artificial valve as described in any embodiment herein, particularly as described in embodiment 9, wherein each support member is connected to two immediately adjacent axial frame members at a corresponding connection point, the connection point being located between a lower end of a first row and an upper end of a second row connected by the corresponding axial frame members.

[0236] Example 12. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 11, wherein at least some of the support members include openings spaced axially from corresponding connection points.

[0237] Example 13. The prosthetic valve according to any of the embodiments herein, particularly any one of embodiments 1-12, wherein the annular frame comprises at least four rows of oblique struts.

[0238] Example 14. The prosthetic valve as described in any embodiment herein, particularly embodiment 13, wherein the annular frame further comprises a third row of oblique struts positioned closer to the inflow end than the second row of oblique struts, and a fourth row of oblique struts defining the inflow end.

[0239] Example 15. The prosthetic valve as described in any embodiment herein, particularly embodiment 14, wherein the third row of oblique struts is narrower than the fourth row of oblique struts.

[0240] Example 16. The prosthetic valve as described in any embodiment herein, in particular embodiment 14 or 15, wherein the second row of oblique struts has the same width as the third row of oblique struts.

[0241] Example 17. The prosthetic valve as described in any embodiment herein, particularly any one of embodiments 14-16, wherein the fourth row of oblique struts has the same width as the first row of oblique struts.

[0242] Example 18. An artificial valve as described in any embodiment herein, particularly any one of embodiments 14-17, wherein the first row of oblique struts, the second row of oblique struts, and the plurality of axial frame members define a plurality of first cells of the annular frame, and the support members divide the first cells into corresponding upper and lower cell portions, the upper cell portions being located closer to the outflow end than the lower cell portions.

[0243] Example 19. The prosthetic valve as described in any embodiment herein, particularly embodiment 18, wherein the first cell has a hexagonal shape when the annular frame is in an expanded configuration.

[0244] Example 20. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 18 or 19, wherein the upper cell portion is larger than the lower cell portion when the annular frame is in an expanded configuration.

[0245] Example 21. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 18 or 19, wherein the lower cell portion is larger than the upper cell portion when the annular frame is in an expanded configuration.

[0246] Example 22. The prosthetic valve as described in any embodiment herein, particularly embodiment 18 or 19, wherein the upper cell portion and the lower cell portion have the same size when the annular frame is in an expanded configuration.

[0247] Example 23. An artificial valve as described in any embodiment herein, particularly any one of embodiments 18 to 22, wherein the lower cell portion has a quadrilateral shape when the annular frame is in an expanded configuration.

[0248] Example 24. An artificial valve as described in any embodiment herein, particularly any one of embodiments 18-22, wherein neither the upper nor lower portion has a quadrilateral shape when the annular frame is in an expanded configuration.

[0249] Example 25. An artificial valve as described in any embodiment herein, particularly any one of embodiments 18-24, wherein the second row of oblique struts and the third row of oblique struts define a plurality of second cells of the annular frame, and the third row of oblique struts and the fourth row of oblique struts define a plurality of third cells of the annular frame.

[0250] Example 26. The prosthetic valve as described in any embodiment herein, particularly embodiment 25, wherein each of the second cell and the third cell has a quadrilateral shape when the annular frame is in an expanded configuration.

[0251] Example 27. The artificial valve as described in any embodiment herein, particularly any one of embodiments 22-26, wherein the second cell and the third cell have different shapes when the annular frame is in an expanded configuration.

[0252] Example 28. An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 1 to 27, wherein each support member includes two arm portions and a joint portion connecting the two arm portions, and each support member is configured to fold at the joint portion when the annular frame transitions from the expanded configuration to the collapsed configuration.

[0253] Example 29. An artificial valve as described in any embodiment herein, particularly as described in embodiment 28, wherein the joint portion of each support member is configured to move axially toward the inflow end when the annular frame transitions from the expanded configuration to the collapsed configuration.

[0254] Example 30. An artificial valve as described in any embodiment herein, particularly as described in embodiment 28, wherein the joint portion of each support member is configured to move axially toward the outflow end when the annular frame transitions from the expanded configuration to the collapsed configuration.

[0255] Example 31. 1. An artificial valve comprising: an annular frame, the annular frame being radially expandable and compressible; and an outer skirt disposed on an outer surface of the annular frame, the annular frame comprising: a first row of oblique struts defining an inflow end, an outflow end, and an outflow end; a second row of oblique struts positioned upstream of the first row of oblique struts; a plurality of axial frame members having corresponding first and second ends, the first ends being connected to the first row of oblique struts and the second ends being connected to the second row of oblique struts; and a plurality of support members connecting the plurality of axial frame members at connection points positioned between the first and second ends, the outer skirt being connected to the support members.

[0256] Example 32. An artificial valve as described in any embodiment herein, particularly as described in embodiment 31, further comprising a plurality of valve leaflets disposed within the annular frame and configured to allow blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end.

[0257] Example 33. An artificial valve as described in any embodiment herein, particularly as described in embodiment 32, wherein the plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial posts located between every two immediately adjacent commissure supports, each commissure support including a commissure window configured to receive a corresponding commissure consisting of two adjacent valve leaflets.

[0258] Example 34. An artificial valve as described in any embodiment herein, particularly as described in embodiment 33, wherein the plurality of axial frame members includes three axially extending commissure supports and exactly two axial posts located between every two immediately adjacent commissure supports.

[0259] Example 35. An artificial valve as described in any embodiment herein, particularly as described in embodiment 33 or 34, wherein at least some of the support members connect to the commissural supports at connection points located between the first end and the commissural window.

[0260] Example 36. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 33 or 34, wherein at least some of the support members connect to the commissural supports at connection points located between the second ends and the commissural windows.

[0261] Example 37. An artificial valve as described in any embodiment herein, particularly any one of embodiments 31 to 36, wherein the support member is narrower in width than the axial frame member, than the first row of oblique struts, and than the second row of oblique struts.

[0262] Example 38. An artificial valve as described in any embodiment herein, particularly any one of embodiments 31-37, wherein the annular frame further comprises a third row of oblique struts located upstream of the second row of oblique struts and a fourth row of oblique struts located upstream of the third row of oblique struts, the fourth row of oblique struts defining an inflow end.

[0263] Example 39. The prosthetic valve as described in any embodiment herein, particularly embodiment 38, wherein the second row of oblique struts and the third row of oblique struts have the same width, and the first row of oblique struts and the fourth row of oblique struts have the same width.

[0264] Example 40. The prosthetic valve as described in any embodiment herein, particularly embodiment 38 or 39, wherein the axial frame member is wider than the first row of oblique struts, the second row of oblique struts, the third row of oblique struts, and the fourth row of oblique struts.

[0265] Example 41. 13. A radially expandable and compressible annular frame comprising: an inflow end; an outflow end; a row of outflow struts defining the outflow end; a row of inflow struts defining the inflow end; an intermediate row of struts axially between the rows of outflow struts; a plurality of axial frame members each having a corresponding first end and a corresponding second end, the first end being connected to the row of outflow struts and the second end being connected to the intermediate row of struts; and a circumferentially extending row of support members axially between the row of outflow struts and the intermediate row of struts, the support members connecting the plurality of axial frame members, each outflow strut including two angled strut portions interconnected by a top portion, the support members being narrower in width than the axial frame members, compared to the angled strut portion of the outflow strut, and compared to struts in the intermediate row of struts.

[0266] Example 42. The annular frame as described in any embodiment herein, particularly embodiment 41, wherein the top portion is narrower in width than the inclined strut portion of the corresponding outflow strut.

[0267] Example 43. The annular frame as described in any embodiment herein, particularly as described in embodiment 41 or 42, wherein each top portion is curved between a pair of two inclined strut portions of a corresponding outflow strut.

[0268] Example 44. An annular frame as described in any embodiment herein, particularly any one of embodiments 41-43, wherein each apex portion has an arc length that extends along at least 25% of the total arc length of the corresponding outflow strut.

[0269] Example 45. The annular frame as described in any embodiment herein, particularly as described in embodiment 41, wherein each top portion forms a U-shaped curved portion between two inclined strut portions of a corresponding outflow strut.

[0270] Example 46. An annular frame as described in any embodiment herein, particularly any one of embodiments 41 to 45, wherein each support member includes two arm portions and a joint portion connecting the two arm portions, and the two arm portions form an obtuse angle at the joint portion when the annular frame is radially expanded.

[0271] Example 47. The annular frame as described in any embodiment herein, particularly embodiment 46, wherein the joint portion forms a U-shaped curved portion between the two arm portions.

[0272] Example 48. An annular frame as described in any embodiment herein, particularly embodiment 46 or 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 configured to move axially toward the outflow end when the annular frame is radially expanded.

[0273] Example 49. An annular frame as described in any embodiment herein, particularly embodiment 46 or 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 configured to move axially toward the inflow end when the annular frame is radially expanded.

[0274] Example 50. The annular frame as described in any embodiment herein, particularly any one of embodiments 46-49, wherein each arm portion is substantially straight.

[0275] Example 51. An annular frame as described in any embodiment herein, particularly any one of embodiments 46 to 50, wherein each arm portion is connected to a corresponding axial frame member via a curved mounting portion.

[0276] Example 52. An annular frame as described in any embodiment herein, particularly any one of embodiments 46 to 51, wherein each support member is configured to be folded at a joint portion such that when the annular frame is radially compressed, the two arm portions extend between and substantially parallel to two immediately adjacent axial frame members.

[0277] Example 53. An annular frame as described in any embodiment herein, particularly any one of embodiments 46 to 52, wherein the joint portion is located closer to the outflow end compared to the second end of the axial frame member when the annular frame is radially expanded.

[0278] Example 54. An annular frame as described in any embodiment herein, particularly embodiment 53, wherein the joint portion is axially aligned to a midpoint between the first end and the second end when the annular frame is radially expanded.

[0279] Example 55. The annular frame according to any embodiment herein, particularly any one of embodiments 41 to 54, wherein the width of the support member is in the range of 0.1 mm to 0.3 mm.

[0280] Example 56. The annular frame according to any embodiment herein, particularly embodiment 55, wherein the width of the support member is in the range of 0.18 mm to 0.22 mm.

[0281] Example 57. The annular frame as described in any embodiment herein, particularly any one of embodiments 41-56, wherein the width of the inclined strut portion of the outflow strut is in the range of 0.3 mm to 0.5 mm.

[0282] Example 58. The annular frame as described in any embodiment herein, particularly embodiment 57, wherein the width of the inclined strut portion of the outflow strut is in the range of 0.38 mm to 0.42 mm.

[0283] Example 59. The annular frame as described in any embodiment herein, particularly any one of embodiments 41-58, wherein the strut width in the intermediate row of struts is in the range of 0.15 mm to 0.35 mm.

[0284] Example 60. The annular frame as described in any embodiment herein, particularly embodiment 59, wherein the strut width in the intermediate row of struts is in the range of 0.23 mm to 0.27 mm.

[0285] Example 61. The annular frame according to any embodiment herein, particularly any one of embodiments 41 to 60, wherein the width of the axial frame member is in the range of 0.2 mm to 2 mm.

[0286] Example 62. The annular frame according to any embodiment herein, particularly embodiment 61, wherein the width of the axial frame member is in the range of 0.8 mm to 1.2 mm.

[0287] Example 63. The annular frame as described in any embodiment herein, particularly any one of embodiments 41-62, wherein the width of the top portion of the outflow struts is in the range of 0.15 mm to 0.25 mm.

[0288] Example 64. The annular frame as described in any embodiment herein, particularly embodiment 63, wherein the width of the top portion of the outflow struts is in the range of 0.18 mm to 0.22 mm.

[0289] Example 65. An annular frame as described in any embodiment herein, particularly any one of embodiments 41 to 64, wherein the intermediate row of struts is a first intermediate row of struts, and one or more additional intermediate rows of struts are provided axially between the first intermediate row of struts and the row of inflow struts.

[0290] Example 66. An annular frame as described in any embodiment herein, particularly as described in embodiment 65, wherein exactly two intermediate rows of struts are provided axially between the rows of outflow struts and the rows of inflow struts.

[0291] Example 67. An annular frame as described in any embodiment herein, particularly any one of embodiments 41 to 66, wherein the plurality of support members are connected to the plurality of axial frame members at connection points located between the first end and the second end.

[0292] Example 68. The annular frame as described in any embodiment herein, particularly embodiment 67, wherein at least some of the axial frame members include openings.

[0293] Example 69. The annular frame as described in any embodiment herein, particularly embodiment 68, wherein the openings are axially spaced apart from the corresponding connection points.

[0294] Example 70. An annular frame as described in any embodiment herein, particularly as described in embodiment 68 or 69, wherein the axial frame member having an opening is wider than the axial frame member not having an opening.

[0295] Example 71. 1. A radially expandable and compressible annular frame comprising: a row of first end struts defining a first end of the annular frame; a row of second end struts defining a second end of the annular frame; a plurality of interconnecting struts arranged in one or more circumferentially extending rows between the first and second row of end struts; a plurality of axial frame members each having a corresponding first and second end, the first end connected to the row of first end struts and the second end connected to the first row of interconnecting struts; and a plurality of support members connecting the plurality of axial frame members at connection points axially located between the first and second ends.

[0296] Example 72. An annular frame as described in any embodiment herein, particularly embodiment 71, wherein the connection point is located axially closer to the first end than the midpoint between the first end and the second end.

[0297] Example 73. An annular frame as described in any embodiment herein, particularly embodiment 71, wherein the midpoint between the first end and the second end is located axially closer to the first end than the connection point.

[0298] Example 74. An annular frame as described in any embodiment herein, particularly any one of embodiments 71 to 73, wherein each support member includes two inclined arm portions and a joint portion connecting the two inclined arm portions.

[0299] Example 75. An annular frame as described in any embodiment herein, particularly embodiment 74, wherein the joint portion of the support member is located axially closer to the second end compared to the connection point when the annular frame is radially expanded.

[0300] Example 76. An annular frame as described in any embodiment herein, particularly embodiment 74, wherein the joint portion of the support member is located axially closer to the first end compared to the connection point when the annular frame is radially expanded.

[0301] Example 77. An annular frame as described in any embodiment herein, particularly any one of embodiments 74 to 76, wherein the joint portion of the support member is located in the axial direction between the first end and the second end of the axial frame member when the annular frame is radially expanded.

[0302] Example 78. An annular frame as described in any embodiment herein, particularly any one of embodiments 74-76, wherein the joint portion is axially aligned with the first end of the axial frame member when the annular frame is radially expanded.

[0303] Example 79. An annular frame as described in any embodiment herein, particularly any one of embodiments 74 to 78, wherein the axial distance between the second end and the joint portion is at least 10 mm when the annular frame is radially expanded.

[0304] Example 80. An annular frame as described in any embodiment herein, particularly embodiment 79, wherein the axial distance between the second end and the joint portion is from one-third to two-thirds of the height of the annular frame when the annular frame is radially expanded, the height of the annular frame being measured between the first end and the second end.

[0305] Example 81. The annular frame as described in any embodiment herein, particularly any one of embodiments 71-80, wherein each first end strut includes two inclined strut portions interconnected by an apex portion.

[0306] Example 82. An annular frame as described in any embodiment herein, particularly embodiment 81, wherein the support member is narrower in width than the axial frame member and than the inclined strut portion of the first end strut.

[0307] Example 83. The annular frame as described in any embodiment herein, particularly any one of embodiments 71-92, wherein the support member comprises a fully annealed metal.

[0308] Example 84. An annular frame as described in any embodiment herein, particularly any one of embodiments 71 to 83, having exactly one circumferentially extending row of interconnecting struts connecting the second ends of multiple axial frame members.

[0309] Example 85. An assembly, comprising: a prosthetic device including a frame, the prosthetic device being transitionable between a radially expanded state and a radially compressed state; and a delivery apparatus configured to deliver the prosthetic device in the radially compressed state to a target location, the frame including a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, and a plurality of axial frame members including corresponding first and second ends, the first ends being spaced apart from the outflow struts. an axial frame member connected to the row of outflow struts at a first end and a second end connected to the row of interconnecting struts; and a plurality of support members connecting the plurality of axial frame members, the plurality of support members extending between the row of outflow struts and the row of interconnecting struts, each outflow strut including two inclined strut portions interconnected by a top portion, the support members being narrower in width than the axial frame members, compared to the inclined strut portions of the outflow struts, and compared to the row of interconnecting struts.

[0310] Example 86. An assembly as described in any embodiment herein, particularly embodiment 85, wherein the plurality of support members are connected to the plurality of axial frame members at connection points located axially between the first and second ends.

[0311] Example 87. The assembly as described in any embodiment herein, particularly as described in embodiment 85 or 86, wherein the prosthetic device further comprises a leaflet structure disposed within the frame and configured to allow blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end.

[0312] Example 88. An assembly as described in any embodiment herein, particularly embodiment 87, wherein the plurality of axial frame members includes a plurality of commissure supports and one or more axial posts located between every two immediately adjacent commissure supports, each commissure support configured to support a corresponding commissure of the leaflet structure.

[0313] Example 89. The assembly described in any embodiment herein, particularly any one of embodiments 85-88, wherein the prosthetic device further comprises an outer skirt disposed on the outer surface of the frame, the outer skirt being connected to the support member.

[0314] Example 90. An assembly as described in any embodiment herein, particularly embodiment 89, wherein the outer skirt extends from the inflow end of the frame to the outflow edge of the outer skirt, and 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.

[0315] Example 91. An assembly as described in any embodiment herein, particularly embodiment 90, wherein the outflow edge of the outer skirt is axially located between the first end and the second end of the axial frame member.

[0316] Example 92. The assembly as described in any embodiment herein, particularly embodiment 90, wherein the outflow edge of the outer skirt is axially aligned with the first end of the axial frame member.

[0317] Example 93. An assembly as described in any embodiment herein, particularly any one of embodiments 85-92, wherein the delivery apparatus includes a balloon shaft and a balloon mounted on a distal end portion of the balloon shaft, and the prosthetic device is compressed onto the balloon during delivery of the prosthetic device to the target location.

[0318] Example 94. An assembly as described in any embodiment herein, particularly any one of embodiments 85 to 92, wherein the prosthetic device is self-expandable from a radially compressed state to a radially expanded state, and the delivery device includes an outer sheath configured to hold the prosthetic device in a radially compressed state while delivering the prosthetic device to the target location.

[0319] Example 95. The assembly described in any embodiment herein, particularly any one of embodiments 85-92, wherein the delivery device includes an actuator coupled to the expansion mechanism of the frame and is configured to expand the prosthetic device from a radially compressed state to a radially expanded state by actuating the actuator.

[0320] Example 96. 13. A method for assembling a prosthetic device comprising: providing an annular frame including a row of outflow struts defining an outflow end of the annular frame; a row of inflow struts defining an inflow end of the annular frame; a row of interconnecting struts extending circumferentially between the rows of outflow struts; and a plurality of axial frame members including corresponding first and second ends, the first end being connected to the row of outflow struts and the second end being connected to the row of interconnecting struts; and bridging the plurality of axial frame members with a plurality of support members, the support members extending circumferentially between the rows of outflow struts and the row of interconnecting struts, each outflow strut including two angled strut portions interconnected by an apex portion, the support members being narrower in width than the axial frame members, compared to the angled strut portions of the outflow struts, and compared to the row of interconnecting struts.

[0321] Example 97. The method of any embodiment herein, particularly embodiment 96, wherein the bridging includes connecting a plurality of support members to a plurality of axial frame members at connection points axially located between the first and second ends.

[0322] Example 98. The method of any embodiment herein, particularly embodiment 96 or 97, further comprising attaching a leaflet structure to the annular frame, the leaflet structure being configured to allow blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end.

[0323] Example 99. The method of any embodiment herein, particularly embodiment 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.

[0324] Example 100. A method as described in any embodiment herein, particularly embodiment 98 or 99, wherein attaching the leaflet structure to the annular frame includes attaching multiple commissures of the leaflet structure to corresponding commissure supports of the annular frame, the commissure supports being selected members of the axial frame members.

[0325] Example 101. The method of any embodiment herein, particularly any one of embodiments 96-100, further comprising attaching an outer skirt to an outer surface of the annular frame.

[0326] Example 102. The method of any embodiment herein, particularly embodiment 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 a plurality of support members.

[0327] Example 103. The method of any embodiment herein, particularly embodiment 101 or 102, 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 axial frame member.

[0328] Example 104. The method of any embodiment herein, particularly any one of embodiments 96-103, further comprising fully annealing the plurality of support members.

[0329] Example 105. A method for assembling a prosthetic device includes providing an annular frame having a row of outflow struts defining an outflow end of the annular frame, a row of inflow struts defining an inflow end of the annular frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, and a plurality of axial frame members each having corresponding first and second ends, the first ends connected to the row of outflow struts and the second ends connected to the row of interconnecting struts. and a plurality of support members connecting the axial frame members, the plurality of support members extending between the row of outflow struts and the row of interconnecting struts; and attaching an outflow skirt to an outer surface of the annular frame, the attachment including connecting an outflow edge portion of the outer skirt to the plurality of support members, each outflow strut including two inclined strut portions interconnected by a top portion, the support members being narrower in width than the axial frame members, than the inclined strut portions of the outflow struts, and than the row of interconnecting struts.

[0330] Example 106. The method includes 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 including a radially expandable and compressible frame, the frame including a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, a row of interconnecting struts extending circumferentially between the rows of outflow struts, and a plurality of axial frame members including corresponding first and second ends, the first ends being spaced apart from the outflow struts. the plurality of axial frame members having a first end connected to a row of outflow struts and a second end connected to the row of interconnecting struts, and a plurality of support members connecting the plurality of axial frame members, the plurality of support members extending between the row of outflow struts and the row of interconnecting struts, each outflow strut including two inclined strut portions interconnected by a top portion, the support members being narrower in width than the axial frame members, compared to the inclined strut portions of the outflow struts, and compared to the row of interconnecting struts.

[0331] Example 107. A prosthetic valve includes an annular frame transitionable between a radially compressed configuration and a radially expanded configuration, the annular frame having an inflow end and an outflow end, and a leaflet structure disposed within the frame, the leaflet structure configured to permit blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end, the frame having a first row of oblique struts defining the outflow end, a second row of oblique struts positioned upstream of the first row of oblique struts, and a second row of oblique struts positioned upstream of the second row of oblique struts. and a third row of oblique struts located adjacent to the first row and a plurality of axial frame members each including a corresponding first end and a second end, the first end connected to the second row of oblique struts and the second end connected to the third row of oblique struts, the plurality of axial frame members including a plurality of axially extending commissural supports and one or more axial posts located between every two immediately adjacent commissural supports, each commissural support configured to support a corresponding commissure of the leaflet structure.

[0332] Example 108. An artificial valve as described in any embodiment herein, particularly embodiment 107, wherein the second row includes two or more inclined struts connecting each pair of adjacent axial frame members.

[0333] Example 109. An artificial valve as described in any embodiment herein, particularly embodiment 107 or 108, wherein the second row of oblique struts are joined in an alternating manner at upper and lower ends, the upper ends being axially located between the lower end and the outflow end, the first row of oblique struts connect the second row of oblique struts at their upper ends, and a plurality of axial frame members are connected to the lower ends.

[0334] Example 110. An artificial valve as described in any embodiment herein, particularly embodiment 107 or 108, wherein the second row of oblique struts are joined in an alternating manner at upper and lower ends, the upper ends being axially located between the lower end and the outflow end, the first row of oblique struts connect the second row of oblique struts at their upper ends, and a plurality of axial frame members are connected to the upper ends.

[0335] Example 111. An artificial valve as described in any embodiment herein, particularly any one of embodiments 107 to 110, wherein the first row of oblique struts has a narrower width than the second row of oblique struts.

[0336] Example 112. An artificial valve as described in any embodiment herein, particularly any one of embodiments 107 to 111, wherein the second row of oblique struts is wider than the third row of oblique struts.

[0337] Example 113. An artificial valve as described in any embodiment herein, particularly any one of embodiments 107-112, wherein the first row of oblique struts and the second row of oblique struts define a plurality of first cells of the frame, and the second row of oblique struts, the third row of oblique struts and a plurality of axial frame members define a plurality of second cells of the frame, the first cells being smaller compared to the second cells when the frame is in a radially expanded configuration.

[0338] Example 114. The prosthetic valve as described in any embodiment herein, particularly embodiment 113, wherein the first cell has a diamond shape when the frame is in a radially expanded configuration.

[0339] Example 115. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 113 or 114, wherein the number of first cells and the number of second cells have a ratio of 1:1.

[0340] Example 116. The artificial valve as described in any embodiment herein, particularly as described in embodiment 113 or 114, wherein the number of first cells and the number of second cells have a ratio of M:1, where M is greater than 1.

[0341] Example 117. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 116, wherein M is equal to 2.

[0342] Example 118. The artificial valve according to any of the Examples herein, particularly according to any one of Examples 113 to 117, wherein the number of the second cells is nine.

[0343] Example 119. An artificial valve as described in any embodiment herein, particularly any one of embodiments 113-118, further comprising a fourth row of oblique struts located upstream of the third row of oblique struts, the third row of oblique struts and the fourth row of oblique struts defining a plurality of third cells of the frame, the third cells being smaller than the second cells when the frame is in a radially expanded configuration.

[0344] Example 120. The prosthetic valve as described in any embodiment herein, particularly embodiment 119, wherein the third cell is larger than the first cell when the frame is in a radially expanded configuration.

[0345] Example 121. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 119 or 120, wherein the number of second cells is equal compared to the number of third cells.

[0346] Example 122. An artificial valve as described in any embodiment herein, particularly any one of embodiments 119-121, further comprising a fifth row of oblique struts located upstream of the fourth row of oblique struts, the fifth row of oblique struts defining an inflow end.

[0347] Example 123. An artificial valve as described in any embodiment herein, particularly any one of embodiments 107 to 114, wherein each of the first row of inclined struts and the second row of inclined struts includes at least four, or more, inclined struts extending between adjacent axial frame members.

[0348] Example 124. a valve prosthesis including an annular frame transitionable between a radially compressed configuration and a radially expanded configuration, the annular frame having an inflow end and an outflow end; and a leaflet structure disposed within the frame, the leaflet structure configured to permit blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end, the frame including a first row of oblique struts defining the outflow end, a second row of oblique struts positioned upstream of the first row of oblique struts, a third row of oblique struts positioned upstream of the second row of oblique struts, and a fourth row of oblique struts positioned upstream of the third row of oblique struts, and first and second ends corresponding to the first row of oblique struts defining the outflow end. and a plurality of axial frame members including ends, a first end connected to a second row of oblique struts and a second end connected to a third row of oblique struts, wherein the first row of oblique struts and the second row of oblique struts define a first plurality of cells of the frame, the second row of oblique struts, the third row of oblique struts and the plurality of axial frame members define a second plurality of cells of the frame, and the third row of oblique struts and a fourth row of oblique struts define a third plurality of cells of the frame, wherein 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.

[0349] Example 125. An artificial valve as described in any embodiment herein, particularly embodiment 124, wherein the plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial posts located between every two immediately adjacent commissure supports, each commissure support configured to support a corresponding commissure of the valve leaflet structure.

[0350] Example 126. The artificial valve as described in any embodiment herein, particularly as described in embodiment 124 or 125, wherein the number of first cells is 18 and the number of second cells is 9.

[0351] Example 127. An artificial valve as described in any embodiment herein, particularly any one of embodiments 124-126, wherein when the frame is in a radially expanded configuration, the first cell is smaller than the third cell, and the third cell is smaller than the second cell.

[0352] Example 128. An annular frame transitionable between a radially compressed configuration and a radially expanded configuration, the annular frame including a first row of inclined struts defining an outflow end, a second row of inclined struts positioned upstream of the first row of inclined struts, a third row of inclined struts positioned upstream of the second row of inclined struts, and a fourth row of inclined struts positioned upstream of the third row of inclined struts, and a plurality of axial frame members each including a first end portion connected to the second row of inclined struts and a second end portion connected to the third row of inclined struts. and a plurality of axial frame members connected to the first and second rows of oblique struts, the first and second rows of oblique struts defining a first plurality of cells of the frame, the second and third rows of oblique struts defining a second plurality of cells of the frame, and the third and fourth rows of oblique struts defining a third plurality of cells of the frame, the first cells being smaller than the third cells and the third cells being smaller than the second cells when the frame is in a radially expanded configuration.

[0353] Example 129. The annular frame as described in any embodiment herein, particularly embodiment 128, wherein the number of first cells is a multiple of the number of second cells, and the number of second cells is equal compared to the number of third cells.

[0354] Example 130. An annular frame as described in any embodiment herein, particularly embodiment 128 or 129, wherein the first row of inclined struts form a plurality of circular arcs when the frame is in a radially expanded configuration.

[0355] Example 131. An annular frame as described in any embodiment herein, particularly any one of embodiments 128-130, wherein the plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial posts located between every two immediately adjacent commissure supports, each commissure support configured to support a corresponding commissure of a leaflet structure mounted within the annular frame.

[0356] Example 132. A prosthetic valve includes an annular frame transitionable between a radially compressed configuration and a radially expanded configuration, the annular frame having an inflow end and an outflow end, and a leaflet structure disposed within the frame, the leaflet structure configured to permit blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end, the frame including a first row of oblique struts defining the outflow end, a second row of oblique struts positioned upstream of the first row of oblique struts, and a third row of oblique struts positioned upstream of the second row of oblique struts. 1. A prosthetic valve comprising: a first row of oblique struts and a plurality of axial frame members bridging the second and third rows of oblique struts, the plurality of axial frame members comprising a plurality of axially extending commissural supports and one or more axial posts located between every two immediately adjacent commissural supports, the second and third rows of oblique struts and the plurality of axial frame members defining a plurality of outflow cells, the frame further comprising one or more axial support struts dividing at least some of the outflow cells in half.

[0357] Example 133. An artificial valve as described in any embodiment herein, particularly embodiment 132, wherein one or more axial support struts have a narrower width compared to the plurality of axial frame members.

[0358] Example 134. An artificial valve as described in any embodiment herein, particularly as described in embodiment 132 or 133, wherein one or more axial support struts have a greater length than the plurality of axial frame members.

[0359] Example 135. 1. An artificial valve comprising: a frame having an inflow end, an outflow end, a row of outflow struts defining the outflow end, the row of inflow struts defining the inflow end, an intermediate row of struts axially located between the rows of outflow struts, a plurality of axial frame members each having a corresponding first end and a second end, the first end being connected to the row of outflow struts and the second end being connected to the intermediate row of struts, and a circumferential row of support members axially located between the rows of outflow struts and the intermediate row of struts, the support members connecting the plurality of axial frame members, each outflow strut including two angled strut portions interconnected by an apex portion, and 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 interface portion of the support member.

[0360] Example 136. An artificial valve as described in any embodiment herein, particularly embodiment 135, wherein the support member is narrower than the axial frame member, than the inclined strut portion of the outflow struts, and than the struts in the middle row of struts.

[0361] Example 137. 1. An artificial valve comprising: a radially expandable and compressible annular frame, the annular frame including a row of outflow struts defining an outflow end of the frame, a row of inflow struts defining an inflow end of the frame, an intermediate row of oblique struts axially located between the rows of outflow struts, a plurality of axial frame members bridging the rows of outflow struts and the intermediate row of oblique struts, and a plurality of support structures connecting the plurality of axial frame members and the intermediate row of oblique struts, each support structure including at least two oblique support arms connecting two immediately adjacent axial frame members and at least one axial support member bridging the at least two oblique support arms and the intermediate row of oblique struts.

[0362] Example 138. The prosthetic valve as described in any embodiment herein, particularly embodiment 137, wherein the angled support arms are narrower compared to the outflow struts and compared to the inflow struts.

[0363] Example 139. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 137 or 138, wherein the axial support member is narrower in width than the axial frame member.

[0364] Example 140. An artificial valve as described in any embodiment herein, particularly any one of embodiments 137 to 139, wherein the angled support arms are narrower than the axial support members.

[0365] Example 141. An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 137 to 140, wherein each axial frame member includes a first end connected to a row of outflow struts, a second end connected to an intermediate row of oblique struts, and connection points at which two oblique support arms of two adjacent support structures located on either side of the axial frame member are connected to the axial frame member.

[0366] Example 142. An artificial valve as described in any embodiment herein, particularly embodiment 141, wherein for each axial frame member, a first end is a connection point.

[0367] Example 143. An artificial valve as described in any embodiment herein, particularly as described in embodiment 141, wherein for each axial frame member, the connection point is axially spaced from the first end.

[0368] Example 144. An artificial valve as described in any embodiment herein, particularly embodiment 143, wherein for each axial frame member, the connection point is closer to the first end than to the second end.

[0369] Example 145. An artificial valve as described in any embodiment herein, particularly any one of embodiments 137 to 144, further comprising an outer skirt disposed on the outer surface of the annular frame, the outer skirt being attached to the inclined support arms of each support structure.

[0370] Example 146. An artificial valve as described in any embodiment herein, particularly any one of embodiments 137 to 145, wherein each support structure includes exactly two angled support arms and exactly one axial support member, the two angled support arms and the one axial support member defining a Y-shaped configuration.

[0371] Example 147. An artificial valve as described in any embodiment herein, particularly embodiment 146, wherein the intermediate row of oblique struts are joined alternately at upper and lower ends, the upper ends being located closer to the outflow end than the lower ends, and the axial support members of the support structure are connected to corresponding lower ends of the intermediate row of oblique struts.

[0372] Example 148. An artificial valve as described in any embodiment herein, particularly embodiment 147, wherein the row of outflow struts, the intermediate row of inclined struts, and the plurality of axial frame members define a plurality of outflow cells, and each support structure divides a corresponding outflow cell into three sub-cells.

[0373] Example 149. The prosthetic valve as described in any embodiment herein, particularly embodiment 148, wherein the three subcells include an upper subcell and two lower subcells, and the upper subcell has a width that is twice the width of each of the lower subcells.

[0374] Example 150. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 148 or 149, wherein the upper subcell has six sides or four sides.

[0375] Example 151. The prosthetic valve according to any of the embodiments herein, particularly any one of embodiments 148-150, wherein each of the lower subcells has a parallelogram shape.

[0376] Example 152. An artificial valve as described in any embodiment herein, particularly any one of embodiments 146 to 151, wherein the intermediate row of inclined struts is the only row of inclined struts extending between the row of outflow struts and the row of inflow struts.

[0377] Example 153. An artificial valve as described in any embodiment herein, particularly any one of embodiments 146-151, wherein the intermediate row of oblique struts is a first intermediate row of oblique struts, and one or more additional intermediate rows of oblique struts are provided between the first intermediate row of oblique struts and the row of inflow struts.

[0378] Example 154. An artificial valve as described in any embodiment herein, particularly as described in embodiment 153, wherein exactly two intermediate rows of inclined struts are provided between the row of outflow struts and the row of inflow struts.

[0379] Example 155. An artificial valve as described in any embodiment herein, particularly as described in embodiment 153, wherein exactly three intermediate rows of inclined struts are provided between the row of outflow struts and the row of inflow struts.

[0380] Example 156. An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 146 to 151, wherein the axial support members of the support structure terminate at corresponding lower ends of an intermediate row of inclined struts.

[0381] Example 157. An artificial valve as described in any embodiment herein, particularly any one of embodiments 146 to 151, wherein the axial support member of the support structure further bridges the intermediate row of oblique struts and the row of inflow struts.

[0382] Example 158. An artificial valve as described in any embodiment herein, particularly embodiment 157, wherein the row of inflow struts defines a plurality of upper ends located downstream of the inflow end, and the axial support members of the support structure connect the lower ends of the intermediate row of inclined struts to corresponding upper ends of the row of inflow struts.

[0383] Example 159. An artificial valve as described in any embodiment herein, particularly embodiment 158, wherein the number of apexes defined by the outflow struts and the number of apexes defined by the inflow struts have a ratio of 1:2.

[0384] Example 160. An artificial valve as described in any embodiment herein, particularly any one of embodiments 146 to 151, wherein the plurality of support structures are first support structures and the annular frame further includes a plurality of second support structures, each of the second support structures including two angled support arms and an axial support member, thereby defining an inverted Y-shaped configuration.

[0385] Example 161. An artificial valve as described in any embodiment herein, particularly as described in embodiment 160, wherein the intermediate row of diagonal struts is a first intermediate row of diagonal struts, the plurality of axial frame members is first axial frame members, and the annular frame further comprises a second intermediate row of diagonal struts located upstream of the first intermediate row of diagonal struts, and a plurality of second axial frame members bridging the second intermediate row of diagonal struts and the row of inflow struts.

[0386] Example 162. An artificial valve as described in any embodiment herein, particularly embodiment 161, wherein the axial support members of the first support structure are connected to the axial support members of the second support structure at a junction between a first intermediate row of inclined struts and a second intermediate row of inclined struts such that each first support structure is a mirror image of a corresponding second support structure.

[0387] Example 163. For each second support structure, two inclined support arms connect two immediately adjacent second axial frame members, and the axial support member bridges the two inclined support arms and a second intermediate row of inclined struts, an artificial valve as described in any embodiment herein, particularly as described in embodiment 161 or 162.

[0388] Example 164. An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 137 to 144, wherein each support structure includes exactly four inclined support arms interconnected to define a W-shaped configuration, the four inclined support arms including two side support arms respectively connected to two adjacent axial frame members and two intermediate support arms disposed between the two side support arms.

[0389] Example 165. An artificial valve as described in any embodiment herein, particularly as described in embodiment 164, wherein exactly six axial frame members are provided.

[0390] Example 166. An artificial valve as described in any embodiment of the present specification, particularly as described in embodiment 164 or 165, wherein the intermediate rows of inclined struts are joined alternately at their upper and lower ends, and each support structure includes an intermediate axial support member connecting the joint portions of two intermediate support arms to corresponding upper ends of the intermediate rows of inclined struts.

[0391] Example 167. An artificial valve as described in any embodiment herein, particularly embodiment 166, wherein the row of outflow struts, the intermediate row of inclined struts, and the plurality of axial frame members define a plurality of outflow cells, and each support structure divides a corresponding outflow cell into an upper sub-cell and two lower sub-cells.

[0392] Example 168. An artificial valve as described in any embodiment herein, particularly embodiment 167, wherein each lower subcell has six sides and the upper subcell has a width that is twice the width of each lower subcell.

[0393] Example 169. An artificial valve as described in any embodiment herein, particularly embodiment 166, wherein each support structure further includes two side axial support members located on either side of the intermediate support member, each side axial support member connecting one of the lower ends of the intermediate row of inclined struts to a joint formed between a side support arm and an adjacent intermediate support arm.

[0394] Example 170. An artificial valve as described in any embodiment herein, particularly embodiment 169, wherein the row of outflow struts, the intermediate row of inclined struts, and the plurality of axial frame members define a plurality of outflow cells, and each support structure divides a corresponding outflow cell into an upper sub-cell and four lower sub-cells.

[0395] Example 171. The prosthetic valve as described in any embodiment herein, particularly embodiment 170, wherein each of the lower subcells has a width that is one-quarter of the width of the upper subcell.

[0396] Example 172. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 170 or 171, wherein each of the lower subcells has a parallelogram shape.

[0397] Example 173. 1. An artificial valve comprising: a radially expandable and compressible annular frame, the annular frame including a row of outflow struts defining an outflow end of the frame; a row of inflow struts defining an inflow end of the frame; first and second intermediate rows of diagonal struts axially located between the rows of outflow struts, the second intermediate row of diagonal struts being located upstream of the first intermediate row of diagonal struts; a plurality of axial frame members bridging the row of outflow struts and the first intermediate row of diagonal struts; and a plurality of support structures connecting the plurality of axial frame members to the first intermediate row of diagonal struts and the second intermediate row of diagonal struts, each support structure including at least two diagonal support arms connecting two immediately adjacent axial frame members and two or more axial support members bridging the at least two diagonal support arms and the first intermediate row of diagonal struts and the second intermediate row of diagonal struts.

[0398] Example 174. The prosthetic valve as described in any embodiment herein, particularly embodiment 173, wherein the angled support arms are narrower than the outflow struts and than the inflow struts.

[0399] Example 175. The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 173 or 174, wherein the axial support member has a narrower width compared to the axial frame member.

[0400] Example 176. An artificial valve as described in any embodiment herein, particularly any one of embodiments 173 to 175, further comprising an outer skirt disposed on the outer surface of the annular frame, the outer skirt being connected to at least a portion of the support structure.

[0401] Example 177. An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 173 to 176, wherein each axial frame member includes a first end connected to a row of outflow struts, a second end connected to a first intermediate row of oblique struts, and connection points at which two oblique support arms of two adjacent support structures located on either side of the axial frame member are connected to the axial frame member.

[0402] Example 178. An artificial valve as described in any embodiment herein, particularly embodiment 177, wherein for each axial frame member, a first end is a connection point.

[0403] Example 179. An artificial valve as described in any embodiment herein, particularly embodiment 177, wherein for each axial frame member, the connection point is axially spaced from the first end.

[0404] Example 180. An artificial valve as described in any embodiment herein, particularly any one of embodiments 177-179, wherein the second end of each axial frame member is connected to two oblique struts in a first intermediate row of oblique struts and is not directly connected to any other oblique struts in the first intermediate row of oblique struts.

[0405] Example 181. An artificial valve as described in any embodiment herein, particularly any one of embodiments 177 to 180, wherein the second intermediate row of oblique struts are joined alternatingly at their upper and lower ends, and each oblique strut in the first intermediate row of oblique struts is connected to one of the upper ends of the second intermediate row of oblique struts.

[0406] Example 182. An artificial valve as described in any embodiment of the present specification, particularly as described in embodiment 181, wherein each support structure includes exactly two oblique support arms, one intermediate axial support member, and two side axial support members, the intermediate axial support member having an upper end connected to the junction of the two oblique support arms, and the two side axial support members having corresponding upper ends connected to corresponding midpoints of the two oblique support arms.

[0407] Example 183. An artificial valve as described in any embodiment herein, particularly embodiment 182, wherein each support structure further includes a connecting support member connecting the midpoints of the two inclined support arms.

[0408] Example 184. An artificial valve as described in any embodiment herein, particularly as described in embodiment 182 or 183, wherein for each support structure, the middle axial support member has a lower end connected to one of the lower ends of the second intermediate row of oblique struts, and the two side axial support members have corresponding lower ends connected to corresponding upper ends of the second intermediate row of oblique struts.

[0409] Example 185. The prosthetic valve as described in any embodiment herein, particularly any one of embodiments 182-184, wherein the row of outflow struts, a first intermediate row of oblique struts, a second intermediate row of oblique struts, and a plurality of axial frame members define a plurality of outflow cells, each support structure dividing a corresponding outflow cell into a plurality of sub-cells, the plurality of sub-cells including a row of four sub-cells, each sub-cell having a parallelogram shape.

[0410] Example 186. An artificial valve as described in any embodiment herein, particularly embodiment 181, wherein each support structure includes eight oblique support arms and four axial support members, each axial support member having an upper end connected to a corresponding junction of two oblique support arms and a lower end connected to a corresponding upper end of a second intermediate row of oblique struts.

[0411] Example 187. The row of outflow struts, a first intermediate row of diagonal struts, a second intermediate row of diagonal struts, and a plurality of axial frame members define a plurality of outflow cells, each support structure dividing a corresponding outflow cell into a plurality of sub-cells, the plurality of sub-cells including a row of five sub-cells, the row of five sub-cells including three sub-cells having six sides positioned between two sub-cells that are parallelogram-shaped, the prosthetic valve as described in any embodiment herein, particularly embodiment 186.

[0412] Example 188. A method comprising sterilizing a prosthetic valve, frame, and / or assembly as described in any of the examples herein, particularly as described in any one of examples 1-95, or particularly as described in any one of examples 107-187.

[0413] Each feature described herein with respect to any example may be combined with other features described in any one or more other examples, unless otherwise stated. For example, one or more features in one frame or prosthesis may be combined with any one or more features in another frame or prosthesis.

[0414] In view of the many possible examples to which the principles of the disclosed technology may be applied, it will 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. Rather, the scope of the claimed subject matter is defined by the following claims, and their equivalents.

Claims

1. An artificial valve, an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration; an outer skirt disposed on an outer surface of the annular frame; The annular frame is An inlet end; The outflow end, a first row of angled struts defining the outflow end; a second row of inclined struts positioned closer to the inflow end than the first row of inclined struts; a plurality of axial frame members spanning the first row of diagonal struts and the second row of diagonal struts; a plurality of support members connecting the plurality of axial frame members; the support member has a narrower width compared to the axial frame member and the first and second rows of diagonal struts; The outer skirt is connected to the support member.

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

3. 3. The prosthetic valve of claim 1, wherein each support member includes two arm portions and a joint portion connecting the two arm portions, and each support member is configured to collapse at the joint portion when the annular frame transitions from the expanded configuration to the collapsed configuration.

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

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

6. An artificial valve, a radially expandable and compressible annular frame; an outer skirt disposed on an outer surface of the annular frame; The annular frame is An inlet end; The outflow end, a first row of inclined struts defining the outflow end, and a second row of inclined struts located upstream of the first row of inclined struts; a plurality of axial frame members including respective first and second ends, the first ends being connected to the first row of diagonal struts and the second ends being connected to the second row of diagonal struts; a plurality of support members connecting the plurality of axial frame members at connection points located between the first end and the second end; The outer skirt is connected to the support member.

7. 7. The prosthetic valve of claim 6, further comprising a plurality of leaflets disposed within the annular frame and configured to permit blood flow from the inflow end to the outflow end and to block blood flow from the outflow end to the inflow end.

8. 8. The prosthetic valve of claim 7, wherein the plurality of axial frame members includes a plurality of axially extending commissural supports and one or more axial posts located between any two immediately adjacent commissural supports, each commissural support including a commissural window configured to receive a corresponding commissure of two adjacent leaflets.

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

10. 10. The prosthetic valve of claim 8 or 9, wherein at least some of the support members connect to the commissural supports at the connection points located between the first ends and the commissural windows.

11. 10. The prosthetic valve of claim 8 or 9, wherein at least some of the support members connect to the commissural supports at the connection points located between the second ends and the commissural windows.

12. 12. The prosthetic valve of claim 6, wherein the support members are narrower in width than the axial frame members and the first and second rows of tilt struts.

13. 13. The artificial valve of claim 6, wherein the annular frame further comprises a third row of oblique struts located upstream of the second row of oblique struts, and a fourth row of oblique struts located upstream of the third row of oblique struts, the fourth row of oblique struts defining the inflow end.

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

15. 15. The prosthetic valve of claim 13 or 14, wherein the axial frame member is wider than any of the first, second, third and fourth rows of tilt struts.

16. A radially expandable and compressible annular frame, a row of first end struts defining a first end of the annular frame; a row of second end struts defining a second end of the annular frame; a plurality of interconnecting struts arranged in one or more circumferentially extending rows between the first row of end struts and the second row of end struts; a plurality of axial frame members including respective first and second ends, the first ends connected to a row of the first end struts and the second ends connected to a first row of interconnecting struts; a plurality of support members connecting the plurality of axial frame members at connection points axially located between the first end and the second end.

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

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

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

22. 22. The annular frame according to claim 19, wherein the joint portion of the support member is located axially between the first end and the second end of the axial frame member when the annular frame is radially expanded.

23. 22. The annular frame of claim 19, 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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